Stroke Motor Recovery for the Hand and Fingers

NCT ID: NCT06604143

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2027-12-31

Brief Summary

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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:

1. Teaching people to reach their movement goals using any strategies they like.
2. 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:

1. Visit the lab for clinical and research assessments on weeks 1, 4, 5, and 15.
2. Complete 10 days of piano training.
3. Undergo magnetic resonance imaging (MRI) scans twice, once in week 1 and once in week 4.

Detailed Description

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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:

1. One group will focus on improving the quality of their movements while playing music on a digital piano.
2. 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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Quality Training Group

Group Type ACTIVE_COMPARATOR

Quality Training

Intervention Type 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.

Goal Training Group

Group Type ACTIVE_COMPARATOR

Goal Training

Intervention Type 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.

Interventions

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Quality Training

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.

Intervention Type BEHAVIORAL

Goal Training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Joyce Chen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joyce L Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto: Faculty of Kinesiology & Physical Education

Locations

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University of Toronto

Toronto, Ontario, Canada

Site Status

Jewish Rehabilitation Hospital

Laval, Quebec, Canada

Site Status

University Institute for Physical Impairment Rehabilitation of Montreal (IURDPM)

Montreal, Quebec, Canada

Site Status

Lethbridge-Layton-Mackay Rehabilitation Center

Montreal, Quebec, Canada

Site Status

Jewish General Hopsital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Joyce L Chen, PhD

Role: CONTACT

416-946-5394

Facility Contacts

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Joyce L Chen, PhD

Role: primary

416-946-5394

Marie-Helene Boudrias, PhD

Role: primary

514-398-5457

Mindy Levin, PhD

Role: backup

514-398-3994

Marie-Helene Boudrias, PhD

Role: primary

514-398-5457

Marie-Helene Boudrias, PhD

Role: primary

514-398-5457

Alexander Thiel, MD

Role: primary

514 340 8222 ext. 22094

Other Identifiers

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G-23-0034937

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

46065

Identifier Type: -

Identifier Source: org_study_id

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