Discovering the Potential for Motor Recovery in People Living With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Finger Individuation: Force
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Quality Training Group
干预措施: Quality Training (Behavioral)
Goal Training Group
干预措施: Goal Training (Behavioral)
结局指标
主要结局
Finger Individuation: Force
时间窗: 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.
Finger Individuation: Joint Angular Excursion
时间窗: 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.
次要结局
- 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))
研究者
Joyce Chen
Associate Professor
University of Toronto