Digital Technology-Informed Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Kinematic movement quality score
研究概览
简要总结
The goal of this study is to determine the effects of lab and home-based technology guidance during movement training post-stroke. The study will compare movement training informed by lab-based technology to training delivered with technology at home. The main questions it aims to answer are:
- How well do lab and home-based technologies help individuals post-stroke improve their movement patterns?
- Is there a difference in improvement between the in-lab and at-home training groups?
- Which technologies lead to the most improvement?
详细描述
The study is a randomized, controlled feasibility trial investigating rehabilitation to improve movement patterns after stroke. The study will recruit participants who have had a stroke that led to upper-extremity impairment. Individuals will be assigned to one of two digital technology-guided groups. One group will be guided through exercises in a home-based setting, the other will be lab-based.
Participants will engage in training sessions multiple days a week for up to 6 weeks, either in-lab or at home. Both groups will visit the lab weekly for movement assessments.
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
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30-85 years.
- •Diagnosis of stroke.
- •Stroke onset of at least six months prior to the time of participation.
- •Fugl Meyer Upper Extremity between 30-50 (mild-moderate)
- •Cognitive skills to consent and actively participate, as indicated by scores of ≥ 24 on the Mini- Mental Status Examination
- •Able to visit lab up to 5x per week for 3 weeks
排除标准
- •Presence of severe aphasia preventing the ability to follow 1-step directions at least 80% of the time.
- •Excessive spasticity of the wrist, elbow, and shoulder, defined as a Modified Ashworth Score >
- •Diagnosis of neurological disorders other than stroke.
- •Orthopedic/musculoskeletal conditions (e.g., severe arthritis) affecting the upper extremity.
- •Currently or planning to become pregnant.
- •Participation in concurrent occupational therapy.
- •Unilateral neglect, defined as failure of the Line Bisection Task
- •Upper extremity pain >= 7/10 on Numeric Rating Scale
研究组 & 干预措施
In-Lab Training
Participants will train in the lab.
干预措施: Lab-based movement guidance (Other)
At-Home Training
Participants will train at-home.
干预措施: Home-based movement guidance (Other)
结局指标
主要结局
Kinematic movement quality score
时间窗: From enrollment to the end of treatment at 3 weeks.
A score based on subject kinematics during a daily task (like reaching), comparing the subject's reaching kinematics to normative kinematics.
次要结局
- FMA-UE Score(From enrollment to the end of treatment at 3 weeks.)
研究者
Scott Uhlrich
Assistant Professor
University of Utah