Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in Hand Dexterity
研究概览
简要总结
In Phase 2, Patients in a community-based setting who have had a stroke will be evaluated by rehabilitation professionals and asked to perform a battery of clinical assessments before and after standard of care and robot assisted therapy with Rehab CARES system of simple force-feedback robots that are adapted to deliver single and group therapy.
详细描述
In Phase 2, we will develop the hardware to allow three haptic robots to dock (a gym) and be configured to allow patients to play therapy games alone or collaboratively. We will test the safety and feasibility of the gym in a community-based rehabilitation setting. We will treat 36 patients randomized to either a control group getting standard of care therapy and a robot group receiving standard of care with upper limb therapy being given using the robot gym instead of an occupational therapist. Therapy will occur over 4 weeks with two follow-up assessments. Key milestones will be to show that the robot group has the same or better functional outcomes, motivation, and adverse events as the control group. Also to show that the robot gym is a cost-effective solution to increasing access to quality rehabilitation care in low-resource, community-based settings. Success here will validate this potential solution, justify design changes revealed via user-feedback and a larger clinical trial.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 and older (based on who is admitted to the CBR site)
- •>3 months post-stroke
- •Stroke diagnosis
- •Diagnosis of hemiparesis as a result of stroke (verified by radiology data)
- •Motor control score on Upper Extremity Fugl-Meyer scale > 15 and < 60;
- •Able to understand and speak
- •Upper arm manual muscle strength scores >1
- •Pain Scores < 8 based on NIH Pain Intensity Scale
排除标准
- •no cerebellum lesions due to stroke
- •severe cognitive function
研究组 & 干预措施
Standard of Care
60 min OT sessions; 3 sessions per week; for 4 weeks;-- augmented Standard therapy - consisting of PT, OT and SLP. Clinical Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2).
干预措施: Standard of Care (Other)
Robot-Assisted Therapy with Rehab CARES system
60 min sessions; 3 sessions per week; for 4 weeks;----of Upper Limb therapy using 1 or more affordable robots. Robot sessions can be group play and/or single play.
Robot Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2)
干预措施: Robot-Assisted Therapy with Rehab CARES system (Device)
结局指标
主要结局
Change in Hand Dexterity
时间窗: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Measured by changes in NIH Toolbox 9-Hole Pegboard Dexterity Test; metric time and # of peg transferred over time. A higher number of pegs means less impaired.
Motivation
时间窗: at pre, at post-intervention (after 12 sessions), at follow-up
Measured by the Self-Assessment Manikin (SAM) scale which consist of 3 subscales: enjoyment, engagement, and control. Each subscale is from 0 to 9. For enjoyment and engagement the higher score is the better and for control the lower score is better.
Change in Motor Control
时间窗: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Measured by Change in Upper Extremity Fugl-Meyer Assessment (UE-FM); scale is out of 66. A lower score means more impaired.
Change in Gross Hand Function
时间窗: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Measured by Changes in Box and Block (BnB) Test; metric # of blocks transferred. A higher score means less impaired.
Motor Control
时间窗: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Measured by Upper Extremity Fugl-Meyer Assessment (UE-FM); scale is out of 66. A lower score means more impaired.
Gross Hand Function
时间窗: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Measured by Box and Block (BnB) Test; metric # of blocks transferred. A higher score means less impaired.
Hand Dexterity
时间窗: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Measured by NIH Toolbox 9-Hole Pegboard Dexterity Test; metric time and # of peg transferred over time. A higher number of pegs means less impaired.
Upper Extremity Function
时间窗: at pre, at post-intervention (after 12 sessions), at follow-up
Measured by Neuro-QoL: Upper Extremity Function - Fine Motor, ADL Short Form. Short form is a self-report on 8 items to assesses fine motor function and activity of daily living in upper arm.
Quality of life (Participation)
时间窗: at pre, at post-intervention (after 12 sessions), at follow-up
Measured by Neuro-QoL: Ability to Participate in Social Role and Activities Short Form.
Quality of life (Satisfaction)
时间窗: at pre, at post-intervention (after 12 sessions), at follow-up
Measured by Neuro-QoL Satisfaction with Social Roles and Activities Short Form.
次要结局
- Change in Cognition(After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up))
- Passive Joint Range of Motion (ROM)(at pre, at post-intervention (after 12 sessions), at follow-up)
- Grip Strength(at pre, at post-intervention (after 12 sessions), at follow-up)
- Executive Function(at pre, at post-intervention (after 12 sessions), at follow-up)
- Exertion Level(at each of 12 therapy sessions)
- Usability(at pre, at post-intervention (after 12 sessions), at follow-up)
- Work Load(at pre, at post-intervention (after 12 sessions), at follow-up)
- Pain Level(at each of 12 therapy sessions)
- Prediction of Motor Function(at pre, at post-intervention (after 12 sessions), at follow-up)
- Prediction of Cognitive Function(at pre, at post-intervention (after 12 sessions), at follow-up)
- Visual Spatial Attention(at pre, at post-intervention (after 12 sessions), at follow-up)
- Active Joint Range of Motion (ROM)(at pre, at post-intervention (after 12 sessions), at follow-up)
- Cognition(After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up))