Stroke Motor Recovery for the Hand and Fingers

Официальное название

Discovering the Potential for Motor Recovery in People Living With Stroke

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Finger Individuation: Force [Срок оценки: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months)]
• Finger Individuation: Joint Angular Excursion [Срок оценки: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).]

Вторичные конечные точки (5)

• Fugl Meyer Upper Limb assessment (FM-UL) [Срок оценки: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).]
• Action Research Arm Test (ARAT) [Срок оценки: Pre-training (baseline), Post-training-1 (day 3), Post-training-2 (day 7), and Follow-up (3 months).]
• Nine-Hole Peg Test (9-HPT) [Срок оценки: 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 [Срок оценки: Baseline and Post-training-1 (day 3)]
• MRI: White matter integrity in corticospinal, reticulospinal and rubrospinal tracts [Срок оценки: Baseline and Post-training-1 (day 3)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Канада · 5 центров

• University of Toronto — Toronto
• Jewish Rehabilitation Hospital — Laval
• University Institute for Physical Impairment Rehabilitation of Montreal (IURDPM) — Montreal
• Lethbridge-Layton-Mackay Rehabilitation Center — Montreal
• Jewish General Hopsital — Montreal

Идентификаторы

NCT: NCT06604143 · 46065 · G-23-0034937

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗