Efficacy of High-dosage, High-intensity Rehabilitation Program on the Motor Recovery After Stroke in Subacute Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Fugl-Meyer upper extremity assessment (FM-UE)
研究概览
简要总结
Intervention abstract
Background: Stroke is the leading cause of long-term disability, and the second leading cause of death in the western world. Most stroke survivors will suffer from motor and cognitive disturbances for the rest of their life, which negatively affects their normal daily life.
Despite the decline in stroke-related mortality over the past decades, the outcome of rehabilitation programs does not improve, and is predictable regardless of the program used. Still, several human and animal studies show that high capacity of training in the early stages post stroke improve motor recovery. This notion is far from being well established.
Aim: Studying the effect of high-dosage, high-intensity training program in the subacute period on upper extremity motor recovery.
Population: Stroke survivors. Study duration: 6 months. Study protocol: Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks. They will be monitored pre and post training, and 6 months post-stroke. Outcome measures will include clinical, kinematic and adherence measures (see complete list in the protocol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Ischemic or hemorrhagic stroke (hemispheric or brainstem) confirmed by CT or MRI
- •First-ever stroke or previous stroke with no upper extremity weakness
- •1 week ≤ Time after stroke onset ≤ 6 weeks
- •Active shoulder flexion of at least 20◦ and partial wrist and/or finger active movement
- •Ability to provide inform consent
排除标准
- •A painful shoulder limiting an active forward reach
- •Severe spasticity or non-neural loss of range of motion
- •Cognitive or communication impairments as determined by the clinical team Unstable medical conditions
结局指标
主要结局
Fugl-Meyer upper extremity assessment (FM-UE)
时间窗: Enrollment, 1 month, 3 months, 6 months after enrollment
The Upper Extremity Fugl-Meyer Assessment (UE-FMA) is a standardized clinical tool designed to evaluate motor impairment in the upper limb following a stroke. It is part of the broader Fugl-Meyer Assessment, one of the most widely used and validated scales in stroke rehabilitation research. The UE-FMA specifically assesses movement, coordination, and reflexes in the shoulder, elbow, forearm, wrist, and hand, with a maximum score of 66 points. The scale is divided into subcomponents, including upper limb movement (36 points), wrist (10 points), hand (14 points), and coordination/speed (6 points). Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), offering a total score that reflects the level of motor impairment-higher scores indicate better motor function. The UE-FMA is valued for its reliability, sensitivity to impairment (rather than function), and its ability to track motor recovery over time.
Action research arm test (ARAT)
时间窗: Enrollment, 1 month, 3 months, 6 months after enrollment
The Action Research Arm Test (ARAT) is a standardized clinical tool used to assess upper limb function following stroke or neurological injury, with a focus on evaluating the ability to perform purposeful, goal-directed tasks. It consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement, each designed to measure different aspects of upper limb activity. Tasks include actions such as picking up small blocks, pouring water, or moving objects across a table. Each item is scored on a 4-point ordinal scale ranging from 0 (no movement) to 3 (normal performance), yielding a maximum total score of 57. The ARAT captures the functional use of the hand and arm in a way that reflects real-world tasks, making it especially relevant for tracking meaningful improvements during rehabilitation. It is known for its high inter-rater and intra-rater reliability and is sensitive to changes in functional performance across a wide spectrum of impairment levels.
Stroke Impact Scale (SIS) hand domain, version 2.0
时间窗: Enrollment, 1 month, 3 months, 6 months after enrollment
The Stroke Impact Scale (SIS) hand domain, version 2.0, is a patient-reported outcome measure that assesses the perceived difficulty of using the affected hand in everyday tasks following a stroke. This domain includes five items that ask individuals to rate the difficulty of performing common activities such as carrying heavy objects, turning a doorknob, or picking up a coin. Each item is scored on a 5-point Likert scale ranging from 1 (could not do it at all) to 5 (not difficult at all), reflecting the patient's experience over the past week. Scores are converted to a 0-100 scale, with higher scores indicating better perceived hand function. The SIS hand domain captures the individual's perspective on the functional impact of stroke on daily activities, providing valuable insight into real-world hand use. It is frequently used in stroke rehabilitation studies to complement performance-based assessments and to evaluate patient-centered outcomes.
Kinematics
时间窗: Enrollment, 1 month, 3 months, 6 months
Using reaching tasks that will be recorded using multiple high resolution video-cameras and analyzed using AI algorithm (OpenPose). Outcome measures that will be examined include: trajectory smoothness, reaching extent, shoulder-elbow synergy, movement time and deviation from trajectories of age matched healthy controls.
次要结局
- Upper extremity activity(Enrollment and 3 months.)
- Time on task(The measure will be recorded every single practice session, twice a day, 5 days a week. Total Time on Task will be calculated at the end of the intervention period, approximately 4 weeks.)
- Attendance(The measure will be recorded every single practice session, twice a day, 5 days a week. Total attendance will be calculated at the end of the intervention period, approximately after 4 weeks.)
- Visual Analogue Scale for pain(The measure will be recorded before and after every single practice session, twice a day, 5 days a week. The mean pain level delta will be calculated at the end of the intervention period, approximately 4 weeks.)
- Rating of perceived exertion (RPE)(The measure will be recorded every single practice session, twice a day, 5 days a week.)
- The Intrinsic Motivation Inventory (IMI)(At the end of the intervention period for each participant (i.e. 4 weeks).)