Lever Actuated Rehabilitation of the Arm Using Wheelchair Propulsion and Computer Gaming
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Fugl-Meyer (FM) Motor Assessment of the Upper Extremity
研究概览
简要总结
This study will test the effectiveness of a new lever drive wheelchair, LARA - Lever Actuated Resonance Assistance. LARA facilitates patients in performing a high amount of practice using their moderate to severely impaired upper extremity after stroke.
Investigators will recruit 44 subjects with subacute strokes to participate in the study through the acute rehabilitation unit of the UC Irvine Douglas Hospital. Study participants will be randomized into 2 groups: LARA therapy group or standard therapy group. The LARA therapy group will use LARA to propel themselves to therapy appointments in the unit and to play video games with the affected upper extremity for 30 mins / day. The standard therapy group will use a standard wheelchair to propel themselves using their unaffected upper and lower extremities. They will be asked to perform a matched duration of standard arm exercises for 30 mins/ day. This program of standard arm exercises was developed by an OT at the Rehabilitation Institute of Chicago which consists of graded-difficulty table-supported exercises.
This study will have 3 assessment visits: baseline, 3 weeks after therapy or upon discharge from the acute rehabilitation unit if sooner, and a 3-month follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of enrollment
- •Stroke onset 1-4 weeks prior to study enrollment
- •Arm motor FM score of < 30 (out of 66) at Baseline Visit
- •Absence of moderate to severe shoulder pain ( Score <3 on the 10 point visual analog pain scale)
- •Any deficit in vision, alertness, language, attention, or other cognitive functions that interfere with playing the LARA games
排除标准
- •Age >80 years at the time of enrollment
- •Severe tone in the affected upper extremities (Score ≥ 4 on the Modified Ashworth Spasticity Scale)
- •Severe language problem that would prevent participants from properly understanding instructions
- •Severe reduced level of consciousness
- •Severe aphasia (score of 3 on the NIH stroke scale (question 9))
- •Severe loss of sensation in stroke-affected upper extremities (Score < 1 on the Nottingham sensory assessment)
- •Currently pregnant
- •Difficulty in understanding or complying with the instructions given by the experimenter
- •Inability to perform the experimental task that will be studied
结局指标
主要结局
Fugl-Meyer (FM) Motor Assessment of the Upper Extremity
时间窗: Baseline, Post-intervention evaluation at 3 weeks, and 3-month evaluation after the end of intervention
We measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to the 3-month follow up evaluation after the end of intervention. Fugl-Meyer is a 66-point scale measuring the movement pattern of the upper extremities. For the study, we analyze the total score only. The higher scores indicate a better outcome.
次要结局
- Timed 10-meter Walk(Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention)
- Modified Ashworth Spasticity Scale(Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention)
- Box and Blocks Test(Baseline, Post-intervention evaluation at 3 weeks, and 3-months after the end of intervention)
研究者
Steven C. Cramer, MD
Professor of Neurology
University of California, Irvine