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| ID | Type | Description | Link |
|---|---|---|---|
| G-23-0034937 | Other Grant/Funding Number | Heart and Stroke Foundation of Canada |
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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
| McGill University | OTHER |
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The goal of this clinical trial is to compare two rehabilitation methods to improve finger movements in people who have had a stroke. The main question it aims to answer is which of these two training methods leads to the most improvement:
There is no one-size-fits-all approach. The second goal is to find out who might benefit more from each method. Some people with stroke may rely on compensatory strategies due to severe impairment, while others with milder strokes might benefit more from techniques that enhance movement quality.
The third goal is to take pictures of the brain to see how it changes with each method. This will help researchers understand how the brain adapts after a stroke and could lead to treatments that target the brain directly.
Participants will:
Forty participants with sub-acute (6 months - 2 years) stroke will be recruited in this multi-site trial taking place in Toronto and Montreal. Participants will need to be able to perform active finger movements. Each site will recruit and randomize participants into one of two training groups. Training will consist of:
Participation in this study will involve 14 visits, each taking place on a separate day.
Piano training consists of 20 hours total, spread over 2 hours per day for 5 days across 2 weeks. Each participant will receive one-on-one and/or group instruction from a Music Therapist with expertise in Neurologic Music Therapy and piano instruction. Exercises will include pressing single keys and multiple keys with different fingers, holding down certain keys while pressing others, and playing melodies and chords with all five fingers, involving various coordination patterns, rhythms, and speeds.
Assessments will be conducted at four timepoints: Baseline, Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months). Participants will undergo validated clinical assessments to evaluate their ability to move and feel their arm, hand, and fingers, as well as for assessor to understand how the stroke has affected them overall. Some of these tests are routinely used by physical therapists and other rehabilitation professionals who work with people living with stroke. For other types of tests, sensors will be placed on their arm, hand, and fingers. These sensors do not emit anything; they will simply record their movements.
Kinetic and kinematic measures will assess finger forces, grip strength, and pinch strength. Magnetic resonance imaging (MRI) scans at Baseline and Post-training-1 will be taken to quantify structure and function of the brain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quality Training Group | Active Comparator |
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| Goal Training Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality Training | Behavioral | Participants will engage in piano playing tasks using their affected hand and fingers. The training focuses on specific aspects of finger movement, and participants will receive feedback related to their playing. They will wear a wrist brace for support, and their hand and arm positions will be monitored to ensure proper technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Finger Individuation: Force | The Finger Individuation - Force is a measure of how well a finger is able to exert force without the other fingers exerting force. This measure has been used to study finger movements in healthy individuals, pianists, and stroke survivors. This task will use a custom device to measure finger movements in all digits of both hands. The forearm will be placed on a table with the wrist in a neutral position and secured to prevent other movements. The device will support the palm and measure the force each finger produces using sensors under each fingertip. The investigators will determine participants' maximum finger force. Then, participants will practice producing forces at 20%, 40%, 60%, and 80% of this maximum for each finger while keeping the others still. They will see a visual target for the required force and get feedback on their performance. | Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months) |
| Finger Individuation: Joint Angular Excursion | The Finger Individuation - Joint Angular Excursion is a measure of how well a finger is able to bend or straighten while the other fingers remain stationary. The angle being measured in this task is the degree of flexion and extension at the finger joints. Specifically, it tracks the movement at the metacarpophalangeal (MCP) joint (i.e., the joint where the finger meets the hand), and proximal interphalangeal (PIP) joint (i.e., joint between the first and second finger bones). Infrared markers will be placed on the metacarpal MCP and PIP joints to track finger movement using two 3-camera Optotrak Certus motion capture systems. | Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Upper Limb assessment (FM-UL) | The FM-UL assessment assesses the sensorimotor impairment in individuals who have had stroke. It assesses movements, coordination, and reflexes. | Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months). |
| Action Research Arm Test (ARAT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joyce L Chen, PhD | Contact | 416-946-5394 | JOYCELYNN.CHEN@UTORONTO.CA |
| Name | Affiliation | Role |
|---|---|---|
| Joyce L Chen, PhD | University of Toronto: Faculty of Kinesiology & Physical Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toronto | Recruiting | Toronto | Ontario | M5S 2W6 | Canada |
IPD used in the results publication
Beginning 3 months and ending 5 years following article publication
Proposals should be directed to JOYCELYNN.CHEN@UTORONTO.CA. To gain access, data requestors will need to sign a data transfer agreement.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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To keep the study fair and unbiased, the participants, principal investigator, and the people analyzing the data won't know which training method each participant is using. This means they will be "blinded" to the study groups. If participants knew why the study groups were chosen and which group they were in, it might affect their performance and the study results.
However, the therapist delivering the piano training will know which method is being used. To reduce bias, this therapist won't be involved in analyzing the data or know the research goals.
|
| Goal Training | Behavioral | Participants will engage in piano playing tasks using their affected hand and fingers. The training emphasizes learning to play and producing music. Feedback will be provided on various aspects of performance such as speed and accuracy, but specific details about finger movement or technique will not be given. The use of a wrist brace and monitoring of hand and arm positions will be consistent with standard practice. |
|
The ARAT is a 19-item assessment designed to evaluate upper extremity motor activity. It measures how well individuals can perform specific arm and hand tasks, focusing on four main areas: grasp, grip, pinch, and gross movement. |
| Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months). |
| Nine-Hole Peg Test (9-HPT) | The 9-HPT is a standardized, quantitative assessment designed to evaluate finger dexterity. In this test, participants are required to pick up pegs from a container one at a time and place them into holes on a pegboard as quickly as possible. | Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months). |
| MRI: Neural activation and connectivity in ipsilesional and contralesional motor cortex | The investigators will examine how various areas of the brain function and interact, with a focus on the regions that control movement. They will specifically assess both the injured side of the brain (ipsilesional) and the uninjured side (contralesional) to observe how each responds during tasks. | Baseline and Post-training-1 (day 3) |
| MRI: White matter integrity in corticospinal, reticulospinal and rubrospinal tracts | The investigators will evaluate the condition of specific brain pathways involved in transmitting signals to participants' muscles, including the corticospinal, reticulospinal, and rubrospinal tracts. | Baseline and Post-training-1 (day 3) |
| Jewish Rehabilitation Hospital | Recruiting | Laval | Quebec | H7V 1R2 | Canada |
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| University Institute for Physical Impairment Rehabilitation of Montreal (IURDPM) | Recruiting | Montreal | Quebec | H3S 2J4 | Canada |
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| Lethbridge-Layton-Mackay Rehabilitation Center | Recruiting | Montreal | Quebec | H4B 1T3 | Canada |
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| Jewish General Hopsital | Recruiting | Montreal | Quebec | H7V 1R2 | Canada |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |