Clinical trial NCT06621771: Playing Piano to Improve Hand Function Early After Stroke
Official title: A Piano Training Program to Improve Manual Dexterity and Upper Extremity Function in Subacute Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Music therapy
Rehabilitation
Intervention
Upper extremity
dexterity
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Jewish Rehabilitation Hospital
First posted: 2024-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Feasibility: Characteristics of stroke participants
timeFrame: Pre-intervention (week0)
measure: Feasibility: Number of eligible vs. referred participants
timeFrame: Post-intervention (week6)
measure: Feasibility: adherence to intervention - number of completed sessions
timeFrame: Post-intervention (week6)
measure: Feasibility: adherence to intervention - number of piano pieces completed (piano group) vs occupational therapy exercises completed (conventional group)
timeFrame: Post-intervention (week6)
measure: Feasibility: adherence to intervention - number of home practice sessions
timeFrame: Post-intervention (week6)
measure: Feasibility: adherence to intervention - time of home practice sessions
timeFrame: Post-intervention (week6)
measure: Feasibility: presence of adverse or undesirable effects during the intervention
timeFrame: Post-Intervention (week6)
measure: Acceptability of the intervention
timeFrame: Post-intervention (week6)
measure: Acceptability: Overall experience
timeFrame: Post-intervention (week6)
Secondary outcomes:
measure: Change from Baseline in the Box and Block test at Post-intervention
timeFrame: Post-intervention (week6) and Follow-up (week12)
measure: Change from Baseline in the Nine Hole Peg Test (NHPT) at Post-intervention
timeFrame: Post-intervention (week6) and Follow-up (week12)
measure: Change from Baseline in the Finger to Nose test at Post-intervention
timeFrame: Post-Intervention (week6) and Follow-up (week12)
measure: Change from Baseline in the Finger Tapping test at Post-intervention
timeFrame: Post-intervention (week6) and Follow-up (week12)
measure: Change from Baseline in the 6-items Jebsen Hand Function test at Post-intervention
timeFrame: Post-intervention (week6) and Follow-up (week12)
measure: Change from Baseline in the Digit Span Test - Forward at Post-intervention
timeFrame: Post-intervention (week6) and Follow-up (week12)
measure: Change from Baseline in the Digit Span Test - Backward at Post-intervention
timeFrame: Post-intervention (week6) and Follow-up (week12)
measure: Change from Baseline in the Hospital Anxiety and Depression Scale at Post-intervention
timeFrame: Post-intervention (week6) and Follow-up (week12)
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Jewish Rehabilitation Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Anouk Lamontagne, PhD
role: PRINCIPAL_INVESTIGATOR
References: