Grau-Sánchez et al. BMC Neurology (2021) 21:19 https://doi.org/10.1186/s12883-020-02019-1 STUDY PROTOCOL Open Access Enriched Music-supported Therapy for chronic stroke patients: a study protocol of a randomised controlled trial Jennifer Grau-Sánchez1,2,3* , Emma Segura1,3, David Sanchez-Pinsach4, Preeti Raghavan5, Thomas F. Münte6, Anna Marie Palumbo7,8, Alan Turry7, Esther Duarte9, Teppo Särkämö10, Jesus Cerquides4, Josep Lluis Arcos4 and Antoni Rodríguez-Fornells1,3,11,12 Abstract Background: Residual motor deficits of the upper limb in patients with chronic stroke are common and have a negative impact on autonomy, participation and quality of life. Music-Supported Therapy (MST) is an effective intervention to enhance motor and cognitive function, emotional well-being and quality of life in chronic stroke patients. We have adapted the original MST training protocol to a home-based intervention, which incorporates increased training intensity and variability, group sessions, and optimisation of learning to promote autonomy and motivation. Methods: A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life of chronic stroke patients when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n = 30) or a control GRASP intervention group (n = 30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. Discussion: We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention. Trial registration: The trial has been registered at ClinicalTrials.gov and identified as NCT04507542 on 8 August 2020. Keywords: Stroke, Rehabilitation, Music therapy, Music-supported therapy * Correspondence: jennifergrau@euit.fdsll.cat 1 Cognition and Brain Plasticity Unit, Bellvitge Biomedical Research Institute, L’Hospitalet de Llobregat, 08907 Barcelona, Spain 2 Escola Universitària d’Infermeria i Teràpia Ocupacional de Terrassa, Autonomous University of Barcelona, C/ de la Riba, 90, 08221 Terrassa, Spain Full list of author information is available at the end of the article © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 2 of 16 Background may help detect errors and adjust future movements Stroke is one of the leading causes of long-term disability [73]. Moreover, playing musical instruments is an worldwide [30]. The reduction of mortality rates, especially activity that involves emotional and motivational as- in developed countries, has resulted in more survivors liv- pects, which can boost motor learning and enhance ing with disability and needing rehabilitation and long-term emotional well-being [70, 88, 94]. care and support [24, 42]. Many stroke patients experience Two recent randomised controlled trials have shown unilateral paresis of the upper extremity, which affects the that MST can lead to similar motor improvements as individual’s autonomy in basic and instrumental activities with standard rehabilitation [28, 32]. A study of 20 of daily living, having a significant impact on participation chronic stroke patients also found that brain plastic and quality of life [17, 39, 55, 89]. changes can occur after MST in the form of cortical Rehabilitation programs for stroke patients are usually motor map reorganisation and enhanced functional delivered immediately following the stroke, when the po- coupling between motor and auditory regions [4, 71]. tential for recovery is thought to be the greatest [40, 86]. Furthermore, Grau-Sánchez et al. [32] showed that pa- Rehabilitation aims to enable the individual to achieve tients with higher sensitivity to music reward were the the highest possible level of functioning in order to ones that showed greater motor improvements after reintegrate the patient into community life [2, 83]. How- MST, a finding that highlights the role of reward and ever, once acute rehabilitation ends, the individual affected motivation on learning during rehabilitation [1, 32, 63]. by stroke faces multiple challenges during the chronic Despite these promising findings, the training protocol stage. More than one third of individuals live with some of MST has some limitations that have precluded wide- residual functional limitations in basic activities, 50% of spread application in the chronic stage. First, MST is often chronic stroke patients need support with instrumental delivered in the hospital or in rehabilitation centres; how- activities of daily living and 65% suffer restrictions in their ever, this form of delivery may not be the most suitable reintegration into community life [35, 55]. These residual option for chronic patients. One of the aims of rehabilita- functional limitations correlate negatively with emotional tion in the chronic phase is reintegration into community well-being and life satisfaction, in particular with regard to life and transitioning to home- and community-based pro- vocational and leisure activities [37, 38, 91]. Despite the grams can assist with such reintegration [65]. Second, recommendations for maintaining an active lifestyle, studies investigating MST usually provide between 15 and stroke survivors show low levels of activity and they may 20 sessions of 30 min during over three or 4 weeks. This even experience functional deterioration during the training intensity is not sufficient in the chronic phase, as chronic phase [6, 12, 31, 58, 92]. However, recovery has training protocols need to be of higher intensity and lon- been shown to continue well into the chronic stage and ger duration to effectively promote recovery [20, 40, 41]. depends on dose and intensity of the interventions Third, only two musical instruments have been used: a provided [20]. Several studies have demonstrated that keyboard and an electronic drum set, which allows train- home and community-based interventions can increase ing fine finger movements and gross arm movements. The functional independence, participation and emotional use of other instruments might improve MST by provid- well-being in chronic stroke patients [13, 29, 34, 78]. In ing a wider range of movements. Fourth, sessions are this vein, there is increasing interest in developing and provided individually, which does not promote social validating interventions for chronic stroke patients aimed interaction with other patients and lack a key components at enhancing physical and psychological well-being [12]. of musical activity, social bonding [19, 25, 60]. Especially One class of music-based intervention for stroke in the chronic stage, patients with stroke often feel lonely motor rehabilitation involve playing musical instruments and deprived of opportunities to engage in meaningful so- with the affected upper extremity following the princi- cial activities [37, 56]. Peer support is particularly relevant ples of motor learning and multimodal stimulation [33]. in rehabilitation since it can increase patients’ quality of These interventions are feasible to apply in the chronic life [44]. Finally, sessions are therapist-led, which in the phase [3, 80]. Among them, Music-Supported Therapy chronic stage, can diminish the patients’ opportunities to (MST) aims to enhance the motor function of the engage in more self-regulated behaviours during their paretic upper limb by following a standardised program learning process [15]. According to recent theories of of keyboard and drum exercises [77]. MST includes motor learning [93], optimization of learning is closely necessary components for promoting motor learning associated with social and intrinsic motivational factors. such as mass repetition of movements, shaping, tailoring, Therefore, interventions focused on strengthening motiv- task variability, instructional language and guidance by ational and self-control aspects could lead to greater the therapist, modelling, and feedback [33]. Of particular recovery [21, 22, 48]. relevance in MST is audio-motor coupling since individuals Considering the above constraints and taking into ac- receive auditory feedback from the musical instrument that count previous experiences in adapting music interventions Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 3 of 16 for home use [26, 87], we have designed a 10-week the latter receiving the Graded Repetitive Arm Supplemen- enriched MST (eMST) training program combining tary Program (GRASP, [36]). The control treatment has individual self-training sessions at home with online peer- already been validated and proven to be effective in enhan- group sessions. Compared to the standard MST program cing the motor function of the upper extremity in chronic eMST features i) increased training intensity and range of stroke patients [18, 28, 36]. movements trained; ii) inclusion of peer-group sessions; iii) Both interventions will comprise of 40 one-hour optimisation of learning through enhanced intrinsic motiv- sessions distributed over 10 weeks (4 sessions per week, ational factors to promote more autonomy; and iv) adapta- 40 h in total). Before and after the treatment, both tion of the program for home use. groups will undergo an evaluation of their motor and The program comprises 40 one-hour sessions (40 h in cognitive function, emotional well-being and quality of total) distributed evenly over 10 weeks (4 sessions/week). life. A follow-up assessment will be conducted at 3 We have also included additional percussion instru- months (Fig. 1). ments to increase the range of movements that patients can train [70]. Considering that participation in social Participants music activities is one of the most important sources of Chronic stroke patients will be recruited from two tertiary reward derived from music [52], we have included group hospitals of the Barcelona metropolitan area (Hospitals sessions once a week to promote social interaction and del Mar i l’Esperança and Bellvitge University Hospital). group bonding [59, 82]. The self-training sessions are These hospitals have stroke units and specialised inpatient delivered at home using an electronic tablet, a keyboard and outpatient neurological rehabilitation departments. and a set of percussion instruments. We have designed Patients diagnosed with ischemic or haemorrhagic an artificial intelligence (AI) platform taking into stroke will be eligible as participants if they fulfil the account recent theories of motor learning to optimise following criteria: presence of mild-to-moderate paresis the learning process by boosting intrinsic motivational of the upper extremity after a stroke defined as having a factors. In the sessions at home, patients are given score between 1 and 4 in the Medical Research Council opportunities to have more control of their behaviours Scale for Muscle Strength at the distal upper limb mus- during the training, which can have a significant impact cles; more than 6 months post-stroke; completion of on feelings of self-competence and autonomy. Moreover, formal rehabilitation programs; no major language or the AI platform uses elements of gamification and cognitive deficits affecting comprehension (Montreal continuously monitors the patient’s performance and Cognitive Evaluation ≥26); no neurological or psychiatric supports therapists in the design and personalization of co-morbidity; and no other musculoskeletal condition training sessions by using prediction and prescription com- affecting upper extremity motor function (e.g. fracture ponents [75]. The adaptation of the program for home use or arthritis). may serve to increase motivation and reward derived from Two clinical researchers will review medical records of music, facilitate learning through self-controlled training stroke patients who had been treated in the rehabilita- and feedback, and enhance mood and quality of life by tion departments of the recruiting hospitals. Phone con- improving self-esteem, competence and autonomy. tacts will be made to screen for potential participants This parallel-group randomised controlled trial will test followed by an appointment to evaluate if the patient the effectiveness of eMST in improving upper extremity fulfils the inclusion criteria. Patients will receive a de- motor function in chronic stroke patients when compared to tailed explanation of the procedures of the study and will a validated program of home-based exercises. Secondary ob- provide written informed consent prior to participation. jectives include testing the effectiveness of this intervention in enhancing cognitive outcomes, emotional well-being, qual- Experimental treatment: enriched music-supported ity of life, and self-regulation and efficacy and compare the therapy program effects of this intervention to a conventional home-based Participants in the eMST-group will follow a 10-week program of upper extremity exercises. We hypothesize that intervention that will consist of 4 weekly one-hour eMST will lead to larger motor and cognitive improvements, sessions (total program duration: 40 h). The training and enhanced emotional well-being and quality of life com- program comprises three individual home-based self- pared with home-based physical exercises alone. training sessions and one group session per week. Methods Individual home-based self-training sessions Study design The individual sessions at home are delivered using an A parallel-group randomised controlled trial will be app on electronic tablets, which provides instructions conducted with participants being randomised to either and cues for patients, records the patient’s performance eMST (eMST-group) or to a control treatment (CT-group), and gathers data about exercises and compliance. At the Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 4 of 16 Fig. 1 Study design. This study is a parallel-randomised controlled trial with two treatment groups (enriched Music-supported Therapy group [eMST- group, n = 30] and Control group [CT-group, n = 30]). Participants will be evaluated before and after the intervention as well as in a 3-month follow up beginning of the intervention program, a therapist visits Percussion exercises In each session, the participant is the patient’s home to provide the materials for treatment presented with an image of four different percussion in- and instructions on the app for home use. The partici- struments and can select the order in which she / he pant is provided with percussion musical instruments would like to play them. For each exercise, the app first (Table 1), an electronic keyboard and an electronic displays a short video demonstrating how to play the par- tablet. In each session, the participant is asked to play ticular instrument and provides instructions to avoid com- four percussion instruments and the electronic key- pensatory movements (Fig. 3a). Then, the participant is board to train gross and fine mobility, respectively. instructed to play the instrument following a rhythmic Table 1 describes the different movements that can pattern as shown on the tablet. The patient is asked to lis- be trained with each instrument. Each individual ses- ten to the rhythmic pattern for later imitation. A visual sion has the same fixed structure (described in Fig. 2) cue provides a countdown to ensure the readiness of the starting with percussion exercises as a warm-up and patient. Then, the patient is asked to reproduce the pat- as a form of gross and fine mobility training (20 min), tern following auditory and visual cues. Table 2 describes followed by keyboard exercises to train fine move- the rhythmic patterns of the percussion exercises, which ments (20 min), an evaluation of the motor perform- are graded by difficulty. The different movements, rhyth- ance and finally, play musical games (15 min). Mood mic patterns and tempo involved in the percussion exer- is evaluated at the end of each session (5 min). cises are presented in Table 3. Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 5 of 16 Table 1 Manual for therapists enriched Music-Supported Therapy: Instruments and movements. This table provides information about the different movements that can be trained with each instrument. For sitting exercises the patient must be seated in a chair without armrests in a comfortable position with both knees and hip at 90°. For standing exercises the patient must be standing up having the chair at their back and with feet slightly separated Instrument Type of movement Body position Movement description Tambourine Shoulder flexion/ Sitting/Standing Position: Hold the tambourine with the unaffected extremity with beater extension (shoulder at 90° and the beater with the affected extremity. Both shoulders and elbow at 0°) should be at 90° with the elbows at 0°. Movement: Hit the tambourine with the beater trying to keep the elbow at 0° to produce movements of shoulder flexion and extension. Shoulder internal/external Sitting/Standing Position: Hold the tambourine with the unaffected extremity rotation and elbow and the beater with the affected extremity. flexion/extension Movement: Hit the tambourine with the beater to produce (elbow at 90°) movements of elbow flexion and extension. Wrist flexion/extension Sitting/Standing Position: Hold the tambourine with the unaffected extremity (shoulder at 0° and elbow and the beater with the affected extremity. at 90°) Movement: Hit the tambourine with the beater trying to keep the elbow at 90° to produce movements of wrist flexion and extension. Tambourine Shoulder abduction/ Standing Position: Hold the tambourine with the affected extremity. adduction (elbow at 0°) Standing up, extremities should drop on either side of the body. Movement: Hit the tambourine in the side of your leg trying to keep the elbow at 0° to produce movements of shoulder abduction/adduction. Shoulder abduction/ Standing Position: Hold the tambourine with the affected extremity. adduction (elbow at 0°) Standing up, extremities should drop on either side of the boy. Movement: Hit the tambourine in the front of your leg trying to keep the elbow at 0° to produce movements of shoulder abduction/adduction. Wrist flexion/extension Standing Position: Hold the tambourine with the affected extremity. (shoulder at 0° and elbow Standing up, extremities should drop on either side of the body. at 0°) Movement: Hit the tambourine in the side of your leg trying to keep the elbow at 0° to produce movements of wrist flexion/ extension. Forearm supination/ Sitting/Standing Position: Hold the tambourine with the affected extremity. The pronation (shoulder at 0° shoulder should be at 0° and elbow at 90°. and elbow at 90°) Movement: Turn your forearm up and down trying to keep the elbow at 90°. Forearm supination/ Sitting/Standing Position: Hold the tambourine with the affected extremity. Hold pronation (shoulder at 90° the tambourine with the affected extremity. The shoulder and elbow at 0°) should be at 90° and elbow at 0°. Movement: Turn your forearm up and down trying to keep the elbow at 0°. Maracas Elbow flexion/extension Sitting/Standing Position: Hold a maraca with the affected extremity. (shoulder at 0°) Movement: Starting with the elbow at 90°, shake the maraca to produce movements of elbow flexion and extension. Wrist flexion/extension Sitting/Standing Position: Hold a maraca with the affected extremity. (shoulder at 0° and elbow Movement: Shake the maraca to produce movements of wrist at 90°) flexion and extension trying to keep the elbow at 90°. Güiro Elbow flexion/extension Sitting Position: Hold the güiro with the unaffected extremity and the (no gravity) stick with the affected extremity. The güiro can rest over the knees and both elbows should be at 0° of flexion. Movement: Rub the sick along the notches of the güiro. Rainstick Forearm supination/ Sitting/Standing Position: Hold the rainstick with the affected extremity. The pronation (shoulder at shoulder should be at 90° with the elbow at 0°. 90° and elbow at 0°) Movement: Turn your forearm up and down. Egg Shaker Elbow flexion/extension Sitting/Standing Position: Hold the egg shaker with the affected extremity. The (shoulder at 0°) shoulder should be at 0° and the elbow at 90°. Movement: Starting with the elbow at 90°, shake the egg to produce movements of elbow flexion and extension. Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 6 of 16 Table 1 Manual for therapists enriched Music-Supported Therapy: Instruments and movements. This table provides information about the different movements that can be trained with each instrument. For sitting exercises the patient must be seated in a chair without armrests in a comfortable position with both knees and hip at 90°. For standing exercises the patient must be standing up having the chair at their back and with feet slightly separated (Continued) Instrument Type of movement Body position Movement description Elbow flexion/extension Sitting/Standing Position: Hold the egg shaker with the affected extremity. (no gravity) Movement: Shake the egg side to side. Wrist flexion/extension Sitting/Standing Position: Hold the egg shaker with the affected extremity. The (shoulder at 0° and elbow shoulder should be at 0° and the elbow at 90°. at 90°) Movement: Shake the egg up and down trying to keep the elbow at 90° to produce movements of wrist flexion and extension. Castanets Fingers mass flexion/ Sitting Position: Hold a castanet with the affected extremity, leaving extension (shoulder at 0° the castanet resting on the palm. The elbow should be at 90° of and elbow at 90°) flexion and shoulder at 0° of flexion. Movement: Press the castanet with the fingers to produce movements of finger mass flexion and extension. Djembe Wrist flexion/extension Sitting Position: Hold the djembe with the nonaffected extremity and (shoulder at 0° and elbow lean it between your knees. The shoulder should be at 0° and at 90°) the elbow at 90°. Movement: Hit the djembe with the affected hand trying to keep the elbow at 90° to produce movements of wrist flexion and extension. Elbow flexion/extension Sitting Position: Hold the djembe with the nonaffected extremity and (shoulder at 0° and elbow lean it between your knees. The shoulder should be at 0° and at 90°) the elbow at 90°. Movement: Hit the djembe with the affected hand trying to shoulder at 0° to produce movements of elbow flexion and extension. Keyboard exercises For the exercises with the keyboard, Games Participants have the possibility to play musical participants are asked to play simple sequences that games, an optional part of the treatment they can skip if gradually increase in difficulty (Fig. 3b). The app pro- they are tired or not in the mood to play. They can vides visual instructions as well as cues to prompt finger choose between four different games: 1) Simon says, movements and records the performance of the patient comprising the participant is asked to repeat a sequence with the keyboard. Exercises with the keyboard increase that is presented, which becomes progressively longer in difficulty depending on the patient’s progress. During and more complex as she / he succeeds; 2) Piano Hero, each exercise, different types of feedback encourage the notes scroll on-screen to the different keys and partici- participant to play as well as they can. A vertical score pants have to play in time to score points; 3) Combo, the bar on the right side of the screen with a star on the top participant plays along songs that are rehearsed during fills up as the participant plays the notes correctly. In the group sessions by accompanying the melody with addition playing an incorrect note causes the screen to the keyboard and/or using the percussion instruments; turn red so that the participants can realize their mistake and 4) Impro, the participant improvises freely on the and play the correct note. keyboard. Fig. 2 Structure of individual sessions Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 7 of 16 Fig. 3 Percussion and keyboard exercises for the home-based individual sessions. a Percussion exercises: instructions for patients. First, there is a video to instruct how the instrument should be played (1) followed by the presentation of the rhythmic pattern (2). After a visual countdown (3), the patient has to reproduce the rhythm with the instrument (4). b Piano exercises: instructions for patients. A drawing of the affected hand is shown (1) followed by a cue that indicates the finger/s that should be used in the exercise (2). After a short clip showing the sequence of notes to be played (3) the patient has to play the keyboard following visual cues (4) Monitoring The keyboard is connected to the elec- prediction, and prescription). All the information is tronic tablet as a midi-device, which allows recording processed to visually summarise the performance of the played notes, any errors made, key-pressure and the patient. To tailor the intervention to the individ- the execution time for each exercise. The AI platform ual needs of the patient, the therapist can virtually is based on three main components (visualisation, prescribe exercises and instruments to be used for each session. The prediction component computes an Table 2 Rhythmic patterns. This table provides the different initial performance estimation based on baseline as- rhythmic patterns that are asked to play in the home-based sessments. The prescription component recommends MST sessions with different percussion instruments appropriate exercises to the therapist by taking into Rhythmic patterns account the performance of the patient and adjusting Level 1 them for difficulty. Since the percussion instruments have no sensors, the AI platform only gathers data re- Level 2 lated to the interaction with the app (watching the video, listening to the rhythm, and starting the Level 3 exercise). Level 4 Daily evaluation At the end of the home-based sessions the motor performance and the mood of the participants Level 5 are evaluated. Five keyboard exercises of 3–5 min duration are applied ranging in difficulty from playing simple Level 6 sequences with one finger to playing complex sequences with five fingers. Moreover, participants are asked to rate Level 7 their mood on a visual scale of emotional faces (from 1 = I am feeling very bad to 5 = I am feeling very good). Partici- pants can also record a voice message for the therapist. Level 8 The therapist’s response is shown at the beginning of the following session. Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 8 of 16 Group sessions preferences, professional and leisure activities, musical Once per week a one-hour virtual group session of music knowledge and previous musical experience and therapy will be conducted using a video communication preferences. platform that is installed in the electronic tablet provided to participants. Participants will be split into groups of 3– Daily evaluation At the end of the group session, each 4 people for the group sessions. A music therapist and an participant will be asked to answer the Participant Post- occupational therapist will conduct the group sessions, Session Questionnaire, consisting of 4 short questions providing instructions for the music therapy exercises. about the feelings of connection to music and the people The sessions involve active and passive music therapy ex- in the group on a 4-point Likert scale. Moreover, the ercises structured into three parts: 1) Beginning, featuring therapists evaluate the overall performance of each pa- warming-up exercises; 2) Core, comprising musical impro- tient as well as their engagement in music making using visation and playing of favourite songs; and 3) Ending, the 9-point Music Engagement Scale adapted from the featuring relaxation exercises. All the exercises will be ac- Music Therapy Communication and Social Interaction companied by live music with the music therapist playing scale (MTCSI; [13]). Each participant is also asked to along on the piano or guitar. Participants will be asked to rate the social connectedness with others following the play musical instruments during the sessions to train gross Inclusion of Other in the Self Scale [6], and participants and fine motor skills, but they can select the musical in- have to rate their mood using a visual scale of emotional struments they wish to play from many different percus- faces (from 1 = I am feeling very bad to 5 = I am feeling sion instruments. Participants will be encouraged to play very good). with the affected extremity to showcase what they have learned during their individual sessions. At the beginning Control treatment: GRASP and the end of the session, therapists will facilitate a dis- Participants in the control intervention group will follow cussion where patients can share their progress, the Graded Repetitive Arm Supplementary Program difficulties and worries. The selection of songs for the (GRASP, [36]). This program consists of self-directed group sessions is done with the participants, taking into arm and hand exercises for stroke patients and it is vali- account their musical preferences. For this reason, a semi- dated to be performed by patients on their own at home. structured interview will be conducted at the beginning of GRASP seeks to promote hand and arm motor function the intervention program to understand cultural recovery through mass repetition of movements and Table 3 Percussion exercises. For each percussion exercise, the movements involved, and the rhytmic pattern and tempo that can be asked to the participant is presented Instrument Movement Rhythmic patterns Tempo Tambourine with beater Shoulder flexion/extension (shoulder at 90° and elbow at 0°) 1, 2, 3 30 Shoulder internal/external rotation and elbow flexion/extension 1, 2, 3, 4, 7, 8 40 (elbow at 90°) Wrist flexion/extension (shoulder at 0° and elbow at 0°) 1, 2, 3, 4, 5, 6, 7, 8 60 Tambourine Shoulder abduction/adduction (elbow at 0°) 1, 2, 3 30 Shoulder abduction/adduction (elbow at 0°) 1, 2, 3 30 Wrist flexion/extension (shoulder at 0° and elbow at 0°) 1, 2, 3, 4, 5, 6, 7, 8 60 Forearm supination/pronation (shoulder at 0° and elbow at 90°) 1, 2, 3, 4, 5, 6, 7, 8 60 Forearm supination/pronation (shoulder at 90° and elbow at 0°) 1, 2, 3, 4, 5, 6, 7, 8 60 Maracas Elbow flexion/extension (shoulder at 0°) 1, 2, 3, 4, 6, 8 50 Wrist flexion/extension (shoulder at 0° and elbow at 90°) 1, 2, 3, 4, 5, 6, 7, 8 60 Güiro Elbow flexion/extension (no gravity) 1, 2, 3, 4, 5, 6, 7, 8 60 Rainstick* Forearm supination/pronation (shoulder at 90° and elbow at 0°) – – Egg Shaker Elbow flexion/extension (shoulder at 0°) 1, 2, 3, 4, 6, 8 50 Elbow flexion/extension (no gravity) 1, 2, 3, 4, 5, 6, 7, 8 60 Wrist flexion/extension (shoulder at 0° and elbow at 90°) 1, 2, 3, 4, 5, 6, 7, 8 60 Castanets Fingers mass flexion/extension (shoulder at 0° and elbow at 90°) 1, 2, 3, 4, 5, 7, 8 60, 70 Djembe Wrist flexion/extension (shoulder at 0° and elbow at 90°) 1, 2, 3, 4, 5, 6, 7, 8 60, 70 Elbow flexion/extension (shoulder at 0° and elbow at 90°) 1, 2, 3, 4, 5, 6, 7, 8 50 Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 9 of 16 task-specific exercises, encouraging the use of the af- in the Wechsler Adult Intelligence Scale, WAIS-IV, [97]; fected extremity in everyday activities. Participants will adapted to Spanish by Pearson Clinical & Talent Assess- be asked to complete 4 weekly one-hour session for 10 ment) to assess working memory, a short version of the weeks (total program duration: 40 h). Boston Naming Test validated in Spanish [14, 47] to assess A booklet describing the exercises and the equipment language production, and the vocabulary subtest of the needed will be provided to participants. Exercises involve WAIS-IV. In addition, the scale and rhythm subtests from arm and hand strengthening, coordination and manual the shortened version of the Montreal Battery of Evalu- skills using everyday objects (e.g., toothpicks, Lego ation of Amusia [68] will be used to screen for amusia at bricks, clothespins or paper clips). The participant will baseline. Participants will complete the Barcelona Music be asked to perform the exercises sitting in a chair or Reward Questionnaire ([51], validated in Spanish) on the next to a table in sets of 5 or 10 repetitions. The number first evaluation to assess individual differences in pleasure of sets and the exercises prescription will be adjusted to derived from musical experiences. Finally, individual differ- the patient’s needs and endurance. ences in perseverance and passion for long-term goals will At the beginning of the intervention, the therapist will be assessed with the Grit Scale ([23]; validated in Spanish in visit the participant’s home to provide instructions and [9]), and social support will be assessed using the Spanish equipment to follow the program. Patients will be asked version of the Multidimensional Scale of Perceived Social to register the type and amount of exercises for each Support ([43, 95]). session on a record sheet. Moreover, after each session, participants will be asked to rate their mood using a Primary outcome visual scale of emotional faces (from 1 = I am feeling very The primary outcome will be upper extremity function bad to 5 = I am feeling very good). The therapist will measured with the Action Research Arm Test (ARAT, contact the participant by phone once a week to monitor [46]). The ARAT is recommended for use in chronic her/his progress and difficulties. stroke and outpatient rehabilitation by the StrokeEDGE Task Force Group [81] and has excellent test-retest and Treatment compliance and withdrawal inter/intra-rater reliability [69, 85]. The measure is a 19- Completion of intervention protocol would require the item test divided into four subtests (grasp, grip, pinch patient to perform ≥80% of the sessions. and gross movement). For each item, the patient is asked to perform a simple task that involves a functional Evaluation movement of the affected upper limb. Each task is rated An initial evaluation will include the collection of demo- using a 4-point ordinal scale. The maximum possible graphical and clinical variables will be performed at score is 57 and the minimal clinically important differ- baseline. In addition, primary and secondary motor, ence is 5.7 points [84]. cognitive and emotional well-being and quality of life outcomes will be evaluated before and after the interven- Secondary outcomes tion as well as at 3-month follow-up. Table 4 summarises the variables and outcomes of the study. Considering the Motor outcomes The upper extremity subtest of the current health crisis due to the COVID-19 pandemic, the Fugl-Meyer Assessment of Motor Recovery after Stroke evaluation will be carried out at the participant’s home in (FMA [27];) will be used to evaluate motor impairment; order to avoid unnecessary visits to the hospital. grip strength will be assessed with a dynamometer and functional movements and dexterity will be assessed Baseline demographic and clinical variables with the Box and Block Test [53] and the Nine Hole Demographic and clinical variables such as age, gender, Pegboard Test [66]. The Chedoke Arm and Hand Activity level of education, living situation, previous musical Inventory will be used to evaluate the patients’ motor training, stroke aetiology and location, and lesion laterality performance in everyday tasks [7]. will be collected from medical records as well as during a The upper extremity subtest of the FMA comprises 33 first interview with the participant. items that evaluate motor impairment in the affected In order to characterise individual differences that can upper limb. The test is divided into 4 sections (shoulder, have a mediating effect on treatment success, we will forearm and elbow, wrist, hand and coordination) asses- evaluate cognitive functions, differences in the process- sing reflexes, flexor and extensor synergies, range of ing and integration of music, music reward, perseverance motion, and overall coordination and speed of the upper and social support at the beginning of the intervention. extremity. Each item is graded using an ordinal scale Therefore, the baseline evaluation will include the Spanish from 0 to 2. The maximum possible score is 66 and the version of the Montreal Cognitive Assessment [45, 62] to minimal clinically important difference for chronic assess global cognitive function, the digit span (included stroke patients is 5.2 points [64]. Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 10 of 16 Table 4 Variables and outcomes of the study Instrument Reference Baseline Post-intervention Follow-up Demographic and clinical variables Montreal Cognitive Assessment [62] • Digit span subtest [97] • Boston Naming Test, short form [47] • Vocabulary subtest [97] • Scale and rhythm subtests Montreal Battery of Evaluation [68] • of Amusia Barcelona Music Reward Questionnaire [51] • Grit scale [23] • Multidimensional Scale of Perceived Social Support [95] • Primary outcome Action Research Arm Test [46] • • • Secondary motor outcomes Fugl-Meyer Assessment of Motor Recovery after Stroke [27] • • • Grip strength [54] • • • Box and Block Test [53] • • • Nine Hole Pegboard Test [66] • • • Chedoke Arm and Hand Activity Inventory [7] • • • Secondary cognitive outcomes • • • Behaviour Rating Inventory of Executive Function [74] • • • Sustained Attention to Response Task [72] • • • Figural memory subtest [90] • • • Rey Auditory Verbal Learning Test [74] • • • Fluency test [89] • • • Secondary emotional well-being and quality of life outcomes Beck Depression Inventory-II [11] • • • Apathy Evaluation Scale [49] • • • Profile of Mood States [57] • • • Stroke Impact Scale [61] • • • Self-regulation and self-efficacy outcomes During intervention Treatment Self-regulation questionnaire [80] • Treatment Questionnaire Concerning Continued Program [80] • Intrinsic Motivation Inventory [79] • Strategies Used to Promote Health Questionnaire [46] • The grip strength will be measured for both hands as The Nine Hole Pegboard Test evaluates fine dexterity the mean of three consecutive trials [54]. by asking the patient to pick up nine pegs and place The Box and Block Test assesses gross manual dex- them into holes on a board and then remove them. The terity by using a setup consisting of a box with 2 patient is asked to complete this task as fast as possible compartments and wood cubes. The participant is and the time needed is scored for the affected and the asked to grasp cubes and transport them from one unaffected hand. The minimal detectable change for this compartment to the other. The number of cubes suc- test is 32.8 s (H. M [16].). cessfully transported within 1 minute is scored for The Chedoke Arm and Hand Activity Inventory is a the affected and the unaffected extremity. The min- performance test that measures the patient’s ability to imal detectable change for the Box and Block Test is perform everyday tasks with both extremities. The test is 5.5 cubes (H. M [16].). composed of 13 different tasks (i.e. open a jar of coffee, Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 11 of 16 make a phone call, clean a pair of eyeglasses) and each min is determined. A recognition test with distractors is task is graded using an ordinal scale from 1 to 7. The also performed at the end of the test. scores are given based on the involvement of the af- The verbal fluency test comprises two tasks: category fected extremity in the task, ranging from less than 25% and letter fluency. The participant is asked to produce as of involvement in the task needing total assistance to many words as possible for a minute of the same seman- complete independence in the task (adequate time and tic category (i.e. animals) or words that start with the safety). The minimal clinically importance difference is same letter (i.e. words starting with ‘p’). The number of 6.3 points [8]. unique words produced is counted as the score for each task. Cognitive outcomes The neuropsychological evaluation will focus on assessing executive function, attention, Emotional well-being and quality of life outcomes visuospatial memory and verbal learning, and fluency. The emotional well-being evaluation will assess depres- Executive function will be evaluated using the Behaviour sion with the Spanish version of the Beck Depression Rating Inventory of Executive Function (BRIEF, [74]; Inventory-II [11, 76], apathy with the Apathy Evaluation validated in Spanish in [10]). The Sustained Attention to Scale translated to Spanish [49] and mood with the Pro- Response Task [72] will be used to assess sustained file of Mood States ([57]; Spanish version by [5]). Health- attention whereas the Figural Memory subtest from the related quality of life will be measured with the Stroke Wechsler Memory Scale-Revised ([90]; adapted to Spanish Impact Scale, which has been translated to Spanish for by Pearson Clinical & Talent Assessment) will evaluate this study [61]. visuospatial memory. Verbal learning will be evaluated The Beck Depression Inventory-II is a self-report meas- using the Spanish version of the Rey Auditory Verbal ure that comprises 21 multiple-choice questions that are Learning Test [50] and a fluency test in Spanish [67] will scored on a scale from 0 to 3. The participant is asked be used to examine verbal fluency. about feelings, thoughts and behaviours of the past The adult version of the BRIEF is a self-report ques- week. Higher scores indicate depression severity and the tionnaire that evaluates executive functioning in every- maximum possible score of the measure is 63. day life situations. The questionnaire includes a self and The Apathy Evaluation Scale evaluates behavioural, informant reports. Both versions comprise 75 items de- cognitive and emotional indicators of apathy. The scale scribing various behaviours, and the participant is asked comprises a self and informant reports both consisting to report if the behaviour is never a problem, sometimes of 18 items that are scored on a 4-point Likert scale, a problem or often a problem. The BRIEF provides two where higher scores indicate more apathy. broad indexes (behavioral regulation and metacognition) The Profile of Mood States evaluates different dimen- as well as an overall score. It includes nine scales that sions of mood by asking the participant to rate feelings assess the ability to inhibit, self-monitor, plan/organize, or emotion felt during the past week. The measure in- shift, initiate, task monitor, emotional control, working cludes 65 items that are scored on a 5-point Likert scale memory, and organization of materials. ranging from 0 “not at all” to 4 “extremely”. The Sustained Attention to Response Task is a compu- The Stroke Impact Scale is a 59-item self-report ques- terised test that evaluates sustained attention by present- tionnaire that assesses muscle strength, hand function, ing the participant with one number at a time and basic and instrumental activities of daily living, global asking him or her to respond as fast as possible when a mobility, communication, emotion, memory and think- target number appears. This test provides measures of ing, and participation. reaction times and changes on this variable over the task, as well as inhibition errors. Self-regulation and self-efficacy outcomes Domain- The Figural Memory subtest from the Wechsler Mem- specific individual differences in motivation and self- ory Scale-Revised [90] measures visuospatial recall and regulation for joining, participating in and engagement recognition memory. The participant is presented with during the rehabilitation program will be assessed with the abstracts designs that later he or she has to identify from Treatment Self-Regulation Questionnaire (adapted from: an array. [80]), the Treatment Questionnaire Concerning Continued The Rey Auditory Verbal Learning Test evaluates ver- Program Participation (adapted from: [80]), and the Intrin- bal learning by asking the patient to recall a list of 15 sic Motivation Inventory [79], respectively. Self-efficacy will words. The list is presented 5 times and after each trial, be measured with the Strategies Used by People to Promote the patient is asked to repeat as many words as he/she Health questionnaire [46]. These questionnaires have been recalls. Then, a second list of words is presented as translated to Spanish for the purpose of the study. interference. The number of words recalled from the The Treatment Self-Regulation Questionnaire is an original list after the interference and after a break of 20 adaptation of the standard version called Academic Self- Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 12 of 16 Regulation Questionnaire (SRQ-A) [80] created for the eMST program requires three participants for the group study. It evaluates the type of self-regulation (external, sessions, randomisation will consider clusters of three interjected, identified or intrinsic) or motivation (exter- participants. The randomisation sequence will be computer- nal or intrinsic) of the participants to engage with the generated and only accessible to a research assistant who rehabilitation program. It is a 15-item self-report ques- will not be involved in the recruitment, treatment or evalu- tionnaire scored on a 7-point scale (1: not all true; 4: ation of participants. This research assistant will inform the somewhat true; 7: very true). The items are questions therapists once the baseline evaluation of the participant is about the reasons why the participants enrolled in the done. current study. Thus, the participants will be asked to answer it only at the beginning of the intervention. Ethical considerations and data management The Treatment Questionnaire Concerning Continued The protocol of this study has been approved by the Program Participation evaluates the type of self-regulation Clinical Research Ethics Committee of the Bellvitge or motivation of the participants for continuing to partici- University Hospital (PR095/17; Barcelona, Spain) and pate in the rehabilitation program to which they have the Hospitals del Mar i l’Esperança (Parc de Salut Mar, been assigned. It is a 15-item self-report questionnaire 2020/9523; Barcelona, Spain) and follows the Declar- scored on a 7-point scale (1: not all true; 4: somewhat true; ation of Helsinki to experiment with human beings. As 7: very true). The items are questions about why the mentioned previously, participants will be informed participants continue to engage with the rehabilitation about study procedures and will sign an informed con- program. Hence, the participants will be asked to sent form prior to participation. Each participant will be complete it only in the middle of the intervention (the 5th identified with a code when collecting demographic and week). clinical variables and outcomes. All the information The Intrinsic Motivation Inventory is a multidimen- gathered by the app will be stored on an internal secure sional measure which assesses the content and level of server from the Artificial Intelligence Research Institute, motivation during an intervention. Therefore, partici- which is maintained by the IT team following institutional pants will be asked to answer it only on completion of security standards. Additionally, patients are de-identified the rehabilitation program. The measure was adapted using the generated code. Connections between the tablet for the current study and consists of 24 self-report ques- and server use a secure credential in an API Rest through tions divided into six different psychological constructs a HTTPS protocol. reflecting positive or negative predictors of intrinsic mo- tivation: 1) interest/enjoyment; 2) perceived competence; 3) effort/importance; 4) pressure/tension; 5) perceived Sample size choice; and 6) value/usefulness. It is scored on a 7-point The sample size calculation is based on a clinically scale (1: not all true; 4: somewhat true; 7: very true). The relevant difference between treatment groups with 80% MST-group will complete 4 additional items on the psy- power and a 5% significance level. Considering that the chological construct of relatedness in order to evaluate minimal detectable change of the ARAT (primary the effect of the group sessions on motivation levels. outcome) is 5.7 points and that an acceptable difference The Strategies Used by People to Promote Health is a between groups of 15% is defined to be clinically mean- 29-item self-report questionnaire that evaluates the de- ingful [84, 85], a sample size of 26 participants will gree of self-care and self-efficacy through four factors be required in each group. From experience gathered consistent with the underlying self-efficacy theory upon in previous studies [32, 77], the dropout rate in this which the scale is based: 1) coping, 2) stress reduction, type of interventions is relatively low (15%). Taking 3) making decisions, and 4) enjoying life. It is scored on this rate into consideration, a final estimation of 60 a 5-point scale (from 1: very little confidence to 5: quite participants is needed in the study, 30 per group. a lot of confidence) and the participants will be asked to answer it in both pre- and post-intervention evaluations. Data analysis Statistical analysis will be performed using R (R Core Blinding Team, 2019) and the Statistical Package for the Social A clinical researcher with expertise in stroke rehabilita- Sciences (SPSS version 21, SPSS inc., Chicago, Illinois, tion will perform the evaluations and will be blinded to USA). For descriptive analyses, quantitative data will be participants’ group allocation. analysed using mean and standard deviation if the data is normally distributed and median and interquartile Randomisation range will be used for variables that are not normally Participants will be randomised to one of the groups distributed. Qualitative variables will be presented using following a block randomisation procedure. As the frequency distributions and percentages. Grau-Sánchez et al. BMC Neurology (2021) 21:19 Page 13 of 16 An intention-to-treat analysis will be performed for all account individual differences that may modulate the outcome variables including all patients that were treatment effect. The outcomes of the study address assigned to a group and for whom the primary outcome various dimensions of functioning, with instruments that was collected at baseline. In the case of participants that evaluate body functions, activity and participation. In withdraw form the study, the score at baseline will be addition, we have included measures of self-regulation assigned for all the evaluation points and reasons for and self-efficacy. Considering that the intervention is withdrawal will be reported. home and community-based, these factors may have a The effect of the intervention on the primary outcome, crucial role in treatment adherence and success. the ARAT, will be assessed using the chi-square test. We expect that patients treated with eMST will show Taking into account the minimal clinically important dif- larger functional improvements than patients treated ference of this test (5.7 points) data will be dichotomized with the control therapy regimen. On the basis that into two categories: clinically improved or unchanged/dete- MST improves several dimensions of functionality beyond riorated. An analysis of covariance (ANCOVA) will be the motor function, we expect that patients will improve carried out for all secondary outcomes to determine differ- their mood and emotional well-being after MST. ences between groups across time using demographical and Abbreviations clinical baseline variables as covariates. The level of signifi- AI: Artificial intelligence; ARAT: Action Research Arm Test; BRIEF: Behaviour cance will be set at p < 0.05 for all statistical tests and Rating Inventory of Executive Function; eMST: Enriched Music-Supported corrected for multiple comparisons when necessary. Therapy; FMA: Fugl-Meyer Assessment of Motor Recovery after Stroke; GRASP: Graded Repetitive Arm Supplementary Program; MST: Music- Supported Therapy; MTCSI: Music Therapy Communication and Social Trial registration Interaction scale The trial has been registered at ClinicalTrials.gov and Acknowledgments identified as NCT04507542. This work was supported by the Ministerio de Ciencia, Innovación y Universidades (ref. PGC2018-099859-B-I00) to A.R.F, by 2017-SGR-172 from Discussion Generalitat de Catalunya to J.L.A. Study resulting from the 201729.30 project, funded by La Marató de TV3. We thank CERCA Programme / Generalitat de Chronic stroke patients with residual motor deficits Catalunya for institutional support. experience limitations in activities of daily living and restrictions in participation in community life [35]. The Trial sponsor Bellvitge Biomedical Research Institute impact of these residual motor deficits on function Avinguda de la Granvia de l’Hospitalet, 199, 08908 coupled with low levels of physical activity can lead to L’Hospitalet de Llobregat, Barcelona - Spain poor emotional well-being, life satisfaction and quality of Authors’ contributions life [12, 38]. There is increasing interest in developing A.R.F., and J.L.A. conceived the study and A.R.F., J.L.A., J.G.S., E.M., D.S.P., and home and community-based interventions for chronic E.D. designed the study. T.F.M., and T.S. contributed to the refinement of the stroke patients to address their needs and improve their study design. J.L.A., D.S.P., and J.C. designed the app to conduct the musical intervention. P.R., A.M.P., and A.T. designed the musical group sessions. All autonomy, participation and overall well-being [13, 34]. authors revised the article and approved the final manuscript. A.R.F. and MST aims at improving motor and cognitive functions, J.L.A. are grant holders for this study. emotional well-being and quality of life in stroke patients Funding and could be a feasible intervention to apply in the Fundació La Marato TV3 (2016, Stroke and traumatic spinal cord and brain chronic phase [32, 71, 79]. We have adapted the original injury program) to A.R.F. and J.L.A. MST program for home use and we have increased train- Availability of data and materials ing intensity and variability, incorporated group sessions, Data and materials can be accessed by contacting the corresponding author and modified the protocol to boost learning by enhancing and in the research group webpage: https://www.brainvitge.org motivation and promoting more autonomy. The incorpor- ation of these changes and the adaptation of the program Ethics approval and consent to participate The study is approved by the ethics committee of Bellvitge University take into account the Medical Research Council Frame- Hospital and Hospitals del Mar i l’Esperança (Barcelona, Spain) and work for Developing and Evaluating Complex Interven- participants will provide written consent to enrol in the study. tions. In order to further develop MST we identified Consent for publication relevant evidence in the literature and developed a theor- In Fig. 3, the second author appears in the figure. We have her consent to etical understanding of the processes of change [33]. use her image. Moreover, we have modelled the intervention process and Competing interests outcomes, and assessed feasibility with a pilot study. All authors declare no conflicts of interest. The study has been designed following the CONSORT guidelines for conducting clinical trials. The evaluation Author details 1 Cognition and Brain Plasticity Unit, Bellvitge Biomedical Research Institute, protocol includes baseline variables such as social sup- L’Hospitalet de Llobregat, 08907 Barcelona, Spain. 2Escola Universitària port, perseverance or musical reward to take into d’Infermeria i Teràpia Ocupacional de Terrassa, Autonomous University of Grau-Sánchez et al. 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