Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Changes in Path Deviations
研究概览
简要总结
The RELEARN trial is a a prospective longitudinal cohort study sampled by convenience. Stroke survivors and healthy control individuals will be recruited to analyze motor learning in the upper extremity and its neural basis in early stroke recovery.
详细描述
In stroke rehabilitation, clinicians guide the relearning of motor skills to promote recovery and improve function. A common assumption is that motor learning interacts with processes that are involved in tissue repair and helps to engage neuroplastic mechanisms that promote recovery. One of the biggest roadblocks for advancing the treatment of motor deficits is that we do not understand how motor learning changes after stroke, and critically, if poor recovery is due to a loss in an individual's ability to adapt or learn. Existing clinical tests do not directly assess motor learning. This means that therapists can profile stroke impairments (motor, sensory, cognitive, etc.) but cannot directly measure a patient's ability to learn, which is likely an important factor in recovery.
The RELEARN trial will pair robotics, an objective tool to assess post-stroke arm impairment, with neuroimaging to link motor learning deficits with possible influencing factors (sensory, motor, cognitive function) and damage in specific brain areas.
Participants with stroke will undergo clinical and robotic evaluations at baseline (within 1-13 days post-stroke), at 6 weeks, at 12 weeks, and again at 26 weeks. An MRI assessment will occur during week 6. Stroke participants will complete a 24hr retention assessment after baseline visit and week 26 visit.
Control participants will undergo a single robotic evaluation and a 24hr retention assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes in Path Deviations
时间窗: Control participant: baseline only; Stroke participant: week 1 and week 26
Initial path deviations (IPDs) will be measured during each robotic task movement and used to measure learning in each session.
Peak Lateral Deviations
时间窗: Stroke participant: week 26
Peak lateral deviations (PLDs) will be measured during each robotic task movement and used to measure learning in each session.
次要结局
- Thumb Localizing Test(Stroke participant only: week 1, week 6, week 12, and week 26)
- Robotic Assessment(Control participant: baseline; Stroke participant: week 1, week 6, week 12, and week 26)
- Apraxia(Stroke participant only: week 1, week 6, week 12, and week 26)
- Magnetic Resonance Imaging (MRI)(Stroke participant only: week 6)
- Chedoke-McMaster Stroke Assessment-Impairment Inventory(Stroke participant only: week 1, week 6, week 12, and week 26)
- Arm Reflexes(Stroke participant only: week 1, week 6, week 12, and week 26)
- Modified Ashworth Scale (MAS)(Stroke participant only: week 1, week 6, week 12, and week 26)
- Strength(Stroke participant only: week 1, week 6, week 12, and week 26)
- Fugl-Meyer Upper Extremity Assessment (FMA)(Stroke participant only: week 1, week 6, week 12, and week 26)
- Functional Independence Measure (FIM)(Stroke participant only: week 1, week 6, week 12, and week 26)
- Motor Learning(Control participant: baseline only; Stroke participant: week 1 and week 26)
- Montreal Cognitive Assessment (MoCA)(Stroke participant only: week 1, week 6, week 12, and week 26)
- Standard of Care Rehabilitation Therapy(Stroke participant only: two days between week 1 and week 26)