- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06604143
Stroke Motor Recovery for the Hand and Fingers
Discovering the Potential for Motor Recovery in People Living With Stroke
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:
- Teaching people to reach their movement goals using any strategies they like.
- Teaching people to improve their movement technique and avoid compensatory strategies.
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:
- Visit the lab for clinical and research assessments on weeks 1, 4, 5, and 15.
- Complete 10 days of piano training.
- Undergo magnetic resonance imaging (MRI) scans twice, once in week 1 and once in week 4.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- One group will focus on improving the quality of their movements while playing music on a digital piano.
- The other group will focus on achieving their movement goals while playing playing music on a digital piano.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joyce L Chen, PhD
- Phone Number: 416-946-5394
- Email: JOYCELYNN.CHEN@UTORONTO.CA
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2W6
- Recruiting
- University of Toronto
-
Contact:
- Joyce L Chen, PhD
- Phone Number: 416-946-5394
- Email: JOYCELYNN.CHEN@UTORONTO.CA
-
Principal Investigator:
- Joyce Chen, PhD
-
-
Quebec
-
Laval, Quebec, Canada, H7V 1R2
- Recruiting
- Jewish Rehabilitation Hospital
-
Contact:
- Marie-Helene Boudrias, PhD
- Phone Number: 514-398-5457
- Email: mh.boudrias@mcgill.ca
-
Principal Investigator:
- Marie-Helene Boudrias, PhD
-
Contact:
- Mindy Levin, PhD
- Phone Number: 514-398-3994
- Email: mindy.levin@mcgill.ca
-
Principal Investigator:
- Mindy Levin, PhD
-
Montreal, Quebec, Canada, H3S 2J4
- Recruiting
- University Institute for Physical Impairment Rehabilitation of Montreal (IURDPM)
-
Contact:
- Marie-Helene Boudrias, PhD
- Phone Number: 514-398-5457
- Email: mh.boudrias@mcgill.ca
-
Principal Investigator:
- Marie-Helene Boudrias, PhD
-
Principal Investigator:
- Mindy Levin, PhD
-
Montreal, Quebec, Canada, H4B 1T3
- Recruiting
- Lethbridge-Layton-Mackay Rehabilitation Center
-
Contact:
- Marie-Helene Boudrias, PhD
- Phone Number: 514-398-5457
- Email: mh.boudrias@mcgill.ca
-
Principal Investigator:
- Marie-Helene Boudrias, PhD
-
Principal Investigator:
- Mindy Levin, PhD
-
Montreal, Quebec, Canada, H7V 1R2
- Recruiting
- Jewish General Hopsital
-
Contact:
- Alexander Thiel, MD
- Phone Number: 22094 514 340 8222
- Email: alexander.thiel@mcgill.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 years of age
- Diagnosis of first time unilateral ischemic or hemorrhagic
- Stroke occurrence: > 6 months and < 2 years
- Able to perform active finger movements (Chedoke-McMaster (CM) Impairment Inventory of the Hand, Stage ≥ 3)
Exclusion Criteria:
- History of developmental, neurological, or major psychiatric disorders
- Cognitive deficits (< 23/30 Montreal Cognitive Assessment)
- Apraxia (<2SD mean Waterloo Apraxia test)
- Neglect (> 40/100, Sunnybrook Neglect Assessment Procedure)
- Cerebellar stroke
- Musculoskeletal injury affecting motor performance
- Inability to sit in a chair and perform exercises for sustained periods
- Contraindications to MRI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Quality Training Group
|
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.
|
|
Active Comparator: Goal Training Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Finger Individuation: Joint Angular Excursion
Time Frame: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).
|
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).
|
|
Finger Individuation: Force
Time Frame: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl Meyer Upper Limb assessment (FM-UL)
Time Frame: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).
|
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)
Time Frame: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).
|
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)
Time Frame: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).
|
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
Time Frame: Baseline and Post-training-1 (day 3)
|
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
Time Frame: Baseline and Post-training-1 (day 3)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joyce L Chen, PhD, University of Toronto: Faculty of Kinesiology & Physical Education
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 46065
- G-23-0034937 (Other Grant/Funding Number: Heart and Stroke Foundation of Canada)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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