Clinical trial NCT06604143: Stroke Motor Recovery for the Hand and Fingers
Official title: Discovering the Potential for Motor Recovery in People Living With Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Motor system
Stroke rehabilitation
Magnetic resonance imaging
Kinematics
Music
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: McGill University
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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. 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Finger Individuation: Force
timeFrame: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months)
measure: Finger Individuation: Joint Angular Excursion
timeFrame: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).
Secondary outcomes:
measure: Fugl Meyer Upper Limb assessment (FM-UL)
timeFrame: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).
measure: Action Research Arm Test (ARAT)
timeFrame: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).
measure: Nine-Hole Peg Test (9-HPT)
timeFrame: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).
measure: MRI: Neural activation and connectivity in ipsilesional and contralesional motor cortex
timeFrame: Baseline and Post-training-1 (day 3)
measure: MRI: White matter integrity in corticospinal, reticulospinal and rubrospinal tracts
timeFrame: Baseline and Post-training-1 (day 3)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Laval
country: Canada
facility: Jewish Rehabilitation Hospital
state: Quebec
city: Montreal
country: Canada
facility: University Institute for Physical Impairment Rehabilitation of Montreal (IURDPM)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hopsital
state: Quebec
city: Montréal
country: Canada
facility: Lethbridge-Layton-Mackay Rehabilitation Center
state: Quebec
Study officials:
affiliation: University of Toronto: Faculty of Kinesiology & Physical Education
name: Joyce L Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: