- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06621771
Playing Piano to Improve Hand Function Early After Stroke
A Piano Training Program to Improve Manual Dexterity and Upper Extremity Function in Subacute Stroke Survivors
The goal of this clinical trial is to study the feasibility of a 6-week piano playing training intervention in a subacute stroke population. More specifically, the investigators aim to (1) implement and test the feasibility of the intervention in the subacute stroke rehabilitation program; and (2) explore the acceptability of the supervised training sessions and home practice sessions. Researchers will also (3) estimate and contrast the effects of the piano training intervention as compared to conventional therapy on manual dexterity, coordination, functional use of the upper extremity, attention and mood.
Therapy specifically provided as part of this project will be delivered above and beyond usual therapy time in both intervention groups. Participants of the piano group will:
- Engage in a step-by-step musical training consisting of two supervised, individual 45-min sessions per week for 6 consecutive weeks, for a total of 12 sessions.
- The supervised session will also be complemented with a biweekly home program (15 minutes) consisting of piano exercises.
Participants in the conventional group will:
- Engage in two individual 45-min sessions per week for 6 consecutive weeks consisting in conventional occupational therapy treatment.
- They will also receive a biweekly home program consisting in occupational therapy exercises (15 minutes).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Piano Training: Musical pieces are designed to involve all 5 digits of the paretic hand. Whether played with the right or left hand, they involve the same number of finger repetitions as well as similar finger sequences and melodic patterns. A Musical Instrument Digital Interface (MIDI) piano program called Synthesia will be used to display musical pieces on a computer screen that is adapted for people with no music reading abilities. Participants will be cued to press a sequence of key presses required to produce a melody by a visual display showing a blue dot falling from the upper part of the screen down to indicate the correct key on a virtual keyboard. After each cue, the program will pause until the participant pressed the correct key before moving on. During the supervised training sessions, participants will play on a touch sensitive piano keyboard. A computer will record the responses from the piano keyboard and provided a final score indicating the number of errors and total duration for each musical piece. A professional therapist will be present during these supervised sessions and will provide verbal feedback on the quality of movement and discouraged compensatory strategies. Nine musical pieces will be introduced to the participants in an order of increasing difficulty: level 1 involving movements of consecutive fingers (e.g.,1-2-3-4-5); level 2 involving third, fourth, and fifth intervals or movements of non-consecutive fingers (e.g., 1-3-5-1-4); and level 3 involving chords, that is 2 fingers played at the same time. Within each level, 3 musical pieces involving an increasing number of key presses and changes in melodic direction will be introduced. The speed of execution or tempo will also increase within each musical piece.
Conventional Intervention: Conventional sessions will consist of usual occupational therapy treatment (e.g., mobility, ADL, IALD, information session), excluding treatments focusing specifically on arm and hand motor recovery. The nature therapy provided as part of the conventional intervention will be carefully documents in the chart.
Home Practice: All participants in the piano group will receive an unsupervised home program consisting of piano sequence exercises comprising short excerpts of the same musical pieces practiced during the supervised sessions and they will receive a roll-up flexible piano. Participants in the conventional group will receive assignments related to occupational therapy exercises and/or IALD/ADLs. All participants will report on their practice duration and content in a logbook after each practice session.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anouk Lamontagne, PhD
- Phone Number: 84168 450-688-9550
- Email: anouk.lamontagne@mcgill.ca
Study Contact Backup
- Name: Myriam Villeneuve, Mec
- Phone Number: 514-216-1295
- Email: myriam.villeneuve@mail.mcgill.ca
Study Locations
-
-
Quebec
-
Laval, Quebec, Canada, H7V1R2
- Recruiting
- Jewish Rehabilitation Hospital
-
Contact:
- Anouk Lamontagne, PhD
- Phone Number: 84168 450-688-9550
- Email: anouk.lamontagne@mcgill.ca
-
Contact:
- Vira Rose
- Phone Number: 84300 450-688-9550
- Email: vrose_hjr@ssss.gouv.qc.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have normal/corrected visual and auditory acuity
- Present a first-ever supratentorial unilateral stroke (1-24 weeks post-stroke)
- Present some capacity of dissociation of arm and finger movements, as reflected by scores of 3 to 6 on the arm and hand components of the Chedoke McMaster Stroke Assessment
- Have the capacity to follow simple instructions
- Have no professional piano experience (only for the piano group)
Exclusion Criteria:
- Presence of visual field defect, hemineglect as well as dementia or moderate-to-severe cognitive deficits (score less than 18 on the Montreal Cognitive Assessment).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Piano group
Participants will engage in a step-by-step musical training consisting of two supervised, individual 45-min sessions per week for 6 consecutive weeks, for a total of 12 sessions.
They will also be asked to practice 2x/week for 15 minutes and they will report on their practice duration and content in a logbook after each practice session.
|
Participants will engage in a step-by-step piano training consisting in playing piano pieces designed to involve all 5 digits of the paretic hand and increasing in complexity.
They will be using a Musical Instrument Digital Interface (MIDI) piano program called Synthesia to display musical pieces on a computer screen that is adapted for people with no music reading abilities and will be playing on a touch sensitive piano keyboard.
The supervised session will also be complemented with a unsupervised home program consisting of piano sequence exercises comprising short excerpts of the same musical pieces practiced during the supervised sessions and they will receive a roll-up flexible piano
|
|
Active Comparator: Conventional group
Participants will engage in two supervised and individual 45-min session per week for 6 consecutive week, consisting in usual occupational therapy treatment.
They will be asked to practice 2x/week for 15 minutes and they will report on their practice duration and content in a logbook after each practice session.
|
Participants will receive conventional occupational therapy treatment (e.g., mobility, ADL, IALD, information session), excluding treatments focusing specifically on arm and hand motor recovery.The supervised session will also be complemented with an unsupervised home program consisting of assignments related to occupational therapy exercises and/or IALD/ADLs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility: Characteristics of stroke participants
Time Frame: Pre-intervention (week0)
|
Collected via chart review (e.g.
CPA vs. outpatient program, age, sex/gender, stroke characteristics, upper extremity function level, cognitive function)
|
Pre-intervention (week0)
|
|
Feasibility: Number of eligible vs. referred participants
Time Frame: Post-intervention (week6)
|
Assessed using the number of participants referred to the study in comparison to the list of admitted patients in the targeted stroke programs.
|
Post-intervention (week6)
|
|
Feasibility: presence of adverse or undesirable effects during the intervention
Time Frame: Post-Intervention (week6)
|
Collected with open-ended questions.
|
Post-Intervention (week6)
|
|
Acceptability: Overall experience
Time Frame: Post-intervention (week6)
|
Investigated through open-ended questions
|
Post-intervention (week6)
|
|
Feasibility: adherence to intervention - number of completed sessions
Time Frame: Post-intervention (week6)
|
Training logbook filled by researchers/clinicians (supervised sessions) and subjects (unsupervised sessions).
|
Post-intervention (week6)
|
|
Feasibility: adherence to intervention - number of piano pieces completed (piano group) vs occupational therapy exercises completed (conventional group)
Time Frame: Post-intervention (week6)
|
Training logbook filled by researchers/clinicians (supervised sessions) and subjects (unsupervised sessions).
|
Post-intervention (week6)
|
|
Feasibility: adherence to intervention - number of home practice sessions
Time Frame: Post-intervention (week6)
|
Training logbook filled by researchers/clinicians (supervised sessions) and subjects (unsupervised sessions).
|
Post-intervention (week6)
|
|
Feasibility: adherence to intervention - time of home practice sessions
Time Frame: Post-intervention (week6)
|
Training logbook filled by researchers/clinicians (supervised sessions) and subjects (unsupervised sessions).
|
Post-intervention (week6)
|
|
Acceptability of the intervention
Time Frame: Post-intervention (week6)
|
Participant's comments and observations collected using the Theoretical Framework of Acceptability (TFA) Questionnaire, which considers different dimensions such as affective attitude, perceived effectiveness, ethicality and opportunity cost.
It comprises 8 items rated from 1 to 5. Minimum value is 8 and maximum value is 40.
A higher score is associated with better outcomes.
|
Post-intervention (week6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Box and Block test at Post-intervention
Time Frame: Post-intervention (week6) and Follow-up (week12)
|
Assess gross manual dexterity
|
Post-intervention (week6) and Follow-up (week12)
|
|
Change from Baseline in the Nine Hole Peg Test (NHPT) at Post-intervention
Time Frame: Post-intervention (week6) and Follow-up (week12)
|
Assesses fine manual dexterity
|
Post-intervention (week6) and Follow-up (week12)
|
|
Change from Baseline in the Finger to Nose test at Post-intervention
Time Frame: Post-Intervention (week6) and Follow-up (week12)
|
Assesses arm movement coordination.
|
Post-Intervention (week6) and Follow-up (week12)
|
|
Change from Baseline in the Finger Tapping test at Post-intervention
Time Frame: Post-intervention (week6) and Follow-up (week12)
|
Assesses finger movement coordination.
|
Post-intervention (week6) and Follow-up (week12)
|
|
Change from Baseline in the 6-items Jebsen Hand Function test at Post-intervention
Time Frame: Post-intervention (week6) and Follow-up (week12)
|
Assesses functional use of the upper extremity.
|
Post-intervention (week6) and Follow-up (week12)
|
|
Change from Baseline in the Hospital Anxiety and Depression Scale at Post-intervention
Time Frame: Post-intervention (week6) and Follow-up (week12)
|
A self-administered test assessing mood, more specifically screening for depression and anxiety.
It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety and seven to depression, giving two scores (maximum score for each = 21).
A higher score is associated with worse outcomes.
|
Post-intervention (week6) and Follow-up (week12)
|
|
Change from Baseline in the Digit Span Test - Forward at Post-intervention
Time Frame: Post-intervention (week6) and Follow-up (week12)
|
A subtest of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) that assesses attention, more specifically auditory recall and working memory.
Score is calculates as the longest number of forward sequential digits that can accurately be remembered.
The maximum score is 16.
A higher score is associated with better outcomes.
|
Post-intervention (week6) and Follow-up (week12)
|
|
Change from Baseline in the Digit Span Test - Backward at Post-intervention
Time Frame: Post-intervention (week6) and Follow-up (week12)
|
A subtest of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) that assesses attention, more specifically auditory recall and working memory.
Score is calculates as the longest number of backward sequential digits that can accurately be remembered.
The maximum score is 16.
A higher score is associated with better outcomes.
|
Post-intervention (week6) and Follow-up (week12)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anouk Lamontagne, PhD, McGill University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-50-2024-2096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
Clinical Trials on Music intervention
-
Da-Yeh UniversityNot yet recruitingAnxiety | Blood Pressure | Heart Rate | Heart Rate Variability (HRV)
-
Guangzhou First People's HospitalActive, not recruiting
-
Nigde Omer Halisdemir UniversityCompletedDental Anxiety | Pain Perception | Fissure Sealant | Dental Procedures | Pediatric Dental PatientsTurkey (Türkiye)
-
Universidade da MadeiraRecruitingHealth People | Survivors of StrokePortugal
-
Toronto Metropolitan UniversityMitacsActive, not recruitingStress, Psychological | Loneliness | Emotion Regulation | Well Being | Executive Functions | Functional AbilitiesCanada
-
Alanya Alaaddin Keykubat UniversityAnkara UniversityCompleted
-
Universidad Miguel Hernandez de ElcheCompletedCardiovascular Diseases | Emergencies | Critical Care | Music Therapy
-
University of Alabama at BirminghamCompleted
-
University Diego PortalesRecruiting
-
Azienda Unita Sanitaria Locale di PiacenzaNot yet recruitingPain | Blood Pressure | Music Therapy | Heart Rate | NursingItaly