Stroke Motor Recovery for the Hand and Fingers

NCT06604143 | Recruiting

• 2 other identifiers: 46065G-23-0034937
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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. 1.Teaching people to reach their movement goals using any strategies they like.
2. 2.Teaching people to improve their movement technique and avoid compensatory strategies.
3. 3.Visit the lab for clinical and research assessments on weeks 1, 4, 5, and 15.
4. 4.Complete 10 days of piano training.
5. 5.Undergo magnetic resonance imaging (MRI) scans twice, once in week 1 and once in week 4.

Conditions

Stroke

Keywords

Motor system; Stroke rehabilitation; Magnetic resonance imaging; Kinematics; Music

Outcome Measures

Primary Outcomes (2)

• 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).

Secondary Outcomes (5)

• Fugl Meyer Upper Limb assessment (FM-UL)

  Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).

• Action Research Arm Test (ARAT)

  Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).

• Nine-Hole Peg Test (9-HPT)

  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

  Baseline and Post-training-1 (day 3)

• MRI: White matter integrity in corticospinal, reticulospinal and rubrospinal tracts

  Baseline and Post-training-1 (day 3)

Study Arms (2)

Quality Training Group

ACTIVE COMPARATOR

Behavioral: Quality Training

Goal Training Group

ACTIVE COMPARATOR

Behavioral: Goal Training

Interventions

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.

Quality Training Group

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.

Goal Training Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Heart and Stroke Foundation of Canada: collaborator
• McGill University: collaborator

Study Sites (5)

University of Toronto

Toronto, Ontario, M5S 2W6, Canada

RECRUITING

Jewish Rehabilitation Hospital

Laval, Quebec, H7V 1R2, Canada

RECRUITING

University Institute for Physical Impairment Rehabilitation of Montreal (IURDPM)

Montreal, Quebec, H3S 2J4, Canada

RECRUITING

Lethbridge-Layton-Mackay Rehabilitation Center

Montreal, Quebec, H4B 1T3, Canada

RECRUITING

Jewish General Hopsital

Montreal, Quebec, H7V 1R2, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Joyce L Chen, PhD

  University of Toronto: Faculty of Kinesiology & Physical Education

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyce L Chen, PhD

CONTACT

416-946-5394; JOYCELYNN.CHEN@UTORONTO.CA

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: May 7, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Proposals should be directed to JOYCELYNN.CHEN@UTORONTO.CA. To gain access, data requestors will need to sign a data transfer agreement.

Locations

CA (5)