Playing Piano to Improve Hand Function Early After Stroke

NCT06621771 | Recruiting

• 1 other identifier: MP-50-2024-2096
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stroke

Keywords

Music therapy; Rehabilitation; Intervention; Upper extremity; dexterity

Outcome Measures

Primary Outcomes (9)

• Feasibility: Characteristics of stroke participants

  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

  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: adherence to intervention - number of completed sessions

  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)

  Training logbook filled by researchers/clinicians (supervised sessions) and subjects (unsupervised sessions).

  Post-intervention (week6)

• Feasibility: adherence to intervention - number of home practice sessions

  Training logbook filled by researchers/clinicians (supervised sessions) and subjects (unsupervised sessions).

  Post-intervention (week6)

• Feasibility: adherence to intervention - time of home practice sessions

  Training logbook filled by researchers/clinicians (supervised sessions) and subjects (unsupervised sessions).

  Post-intervention (week6)

• Feasibility: presence of adverse or undesirable effects during the intervention

  Collected with open-ended questions.

  Post-Intervention (week6)

• Acceptability of the intervention

  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)

• Acceptability: Overall experience

  Investigated through open-ended questions

  Post-intervention (week6)

Secondary Outcomes (8)

• Change from Baseline in the Box and Block test at Post-intervention

  Post-intervention (week6) and Follow-up (week12)

• Change from Baseline in the Nine Hole Peg Test (NHPT) at Post-intervention

  Post-intervention (week6) and Follow-up (week12)

• Change from Baseline in the Finger to Nose test at Post-intervention

  Post-Intervention (week6) and Follow-up (week12)

• Change from Baseline in the Finger Tapping test at Post-intervention

  Post-intervention (week6) and Follow-up (week12)

• Change from Baseline in the 6-items Jebsen Hand Function test at Post-intervention

  Post-intervention (week6) and Follow-up (week12)

Study Arms (2)

Piano group

EXPERIMENTAL

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.

Other: Music intervention

Conventional group

ACTIVE COMPARATOR

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.

Other: Occupational Therapy

Interventions

Music intervention OTHER

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

Piano group

Occupational Therapy OTHER

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.

Conventional group

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• McGill University: lead
• Jewish Rehabilitation Hospital: collaborator

Study Sites (1)

Jewish Rehabilitation Hospital

Laval, Quebec, H7V1R2, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Anouk Lamontagne, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anouk Lamontagne, PhD

CONTACT

450-688-9550; anouk.lamontagne@mcgill.ca

Myriam Villeneuve, Mec

CONTACT

514-216-1295; myriam.villeneuve@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Experimental study involving a repeated-measure designed of two groups of participants with stroke, i.e., those receiving piano training sessions and those receiving additional conventional occupational therapy sessions.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: October 15, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 6 months after study completion
• Access Criteria: Data will be made available to other researchers via an institutional data repository that will allow adhering to FAIR principles.

Locations

CA (1)