FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Motor Activity Log
研究概览
简要总结
The investigators will investigate the efficacy of a newly developed functional exercise device (FitMi Plus) for people in the chronic stage after a stroke compared to the FitMi Basic (i.e. without functional exercises). FitMi Plus combines objects commonly used during activities of daily living with sensors that can track and record the patient's direction and degree of movement as they perform specific functional tasks described on a computer.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experienced 1 or more strokes >6 months prior to enrollment
- •Upper Extremity Fugl-Meyer Score >=15 and <=55 out of 66
- •Absence of moderate to severe upper extremity pain (<= 4 out of 10 on the visual-analog pain scale)
- •Ability to understand the instructions to operate FitMi products
排除标准
- •Lack of concurrent severe medical problems
- •Lack of visual deficits
- •Lack of severe neglect or apraxia
- •No concurrent enrollment in another therapy study
研究组 & 干预措施
FitMi Plus
Participants will perform targeted movement exercises by interacting with the FitMi Plus Functional modules at least 50% of the time they spend exercising.
Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.
干预措施: FitMi Plus (Device)
FitMi Basic
Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer.
Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.
干预措施: FitMi Basic (Device)
结局指标
主要结局
Change in Motor Activity Log
时间窗: Baseline and One-Month Post-Treatment, at seven weeks
A self-reported measure of the quality of movement and amount of use of the impaired upper extremity across a set of activities of daily living. Minimum value = 0, maximum value = 5, higher scores = better outcome
次要结局
- Change in Upper Extremity Fugl-Meyer(Baseline and One-Month Post-Treatment, at seven weeks)
研究者
Flint Rehabilitation Devices, LLC
Vice President
Flint Rehabilitation Devices, LLC