MiGo Tracker: Seamless Remote Therapeutic Monitoring of Exercise Adherence After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Upper Extremity Fugl-Meyer from Baseline
研究概览
简要总结
This project will determine the safety and effectiveness of a MiGo Tracker RTM program in a randomized controlled trial with individuals with subacute stroke (N=50). Participants will be randomly assigned to either the MiGo Tracker RTM program (intervention group) or prescription of home exercises with no monitoring (usual care/control group). All participants will still receive usual post-stroke care, including outpatient rehabilitation. The main question this study aims to answer is: Does a MiGo Tracker RTM program lead to significantly greater motor recovery at three-months post stroke than the usual care group. If successful, MiGo Tracker will lead to increased home exercise adherence and improved health outcomes for thousands of individuals following stroke.
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)
盲法说明
Assessor blinded
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
- •Experienced one or more strokes less than one month (30 days) prior
- •Upper Extremity Fugl-Meyer Score > 5 and <= 55 out of 66
- •Absence of moderate to severe pain (<= 4 on the 10 point visual-analog pain scale)
排除标准
- •age <18 years old
- •Unable to follow 2-step commands
- •Other neurological diagnosis (e.g. Parkinson's Disease)
- •Other severe concurrent medical conditions that may prevent the participants from completing the 3-month study
研究组 & 干预措施
MiGo Tracker enabled RTM Program
Participants will be provided a MiGo Tracker device which will log all home exercise sessions and uploaded to the MiGo-RTM dashboard. The supervising study therapist will conduct weekly phone calls with each participant where they review exercise metrics and assist with any barriers or issues.
干预措施: MiGo Tracker (Device)
Conventional Standard of Care
Participants will be assigned a home exercise regimen designed by a study therapist based on the individual participant's specific goals and abilities.
干预措施: Conventional home exercise program (Other)
结局指标
主要结局
Change in Upper Extremity Fugl-Meyer from Baseline
时间窗: Baseline and 3 months post stroke
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation, balance, joint range of motion and joint pain in patients with post-stroke hemiplegia. A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks. Minimum value = 0, maximum value = 66, higher scores = better outcome
次要结局
- Change in Action Research Arm Test from Baseline(Baseline and 3 months post stroke)
- Change in Box and Blocks from Baseline(Baseline and 3 months post stroke)
- Change in Motor Activity Log from Baseline(Baseline and 3 months post stroke)
- Change in Modified Ashworth Spasticity Scale from Baseline(Baseline and 3 months post stroke)
- Change in Visual Analog Pain Scale from Baseline(Baseline and 3 months post stroke)