Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Kinematic Assessment:Smoothness in 1/s2
研究概览
简要总结
The purpose of this clinical trial is to investigate the efficacy of a hybrid-based rehabilitation program for the upper extremity(UE) combining the interventions- Functional Electrical Stimulation (FES) and Robotic rehabilitation in individuals with chronic stroke. The main question it aims to answer is if the Hybrid multi-muscle FES+Robot upper extremity rehabilitation is more effective in improving the upper extremity motor impairments and function as compared to robotic upper extremity training alone.
详细描述
Individuals with chronic stroke(> 6months after stroke) will be recruited. All participants will complete clinical and kinematic assessments at 2 time points(baseline and after 6 weeks training). Each participant will receive 18 sessions of 60 minute upper extremity training over 6 weeks.
Study participants will be randomly assigned to receive either of the following upper extremity training- 1. Hybrid multi-muscle FES+Robot training group or 2.Robot only training group.
The following clinical assessments to measure the motor impairments and functional recovery will be performed: Fugl-Meyer Upper Extremity, Modified Ashworth Scale, and Wolf Motor Function Test.
Kinematic assessments will be conducted using the REACH robotic device and the Kinereach/trakStar system. The following kinematic parameters will be collected: Smoothness, Range of Motion, and Speed.
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
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with chronic stroke(>6months post stroke)
- •Age-22-85 years old
- •Ability to perform a Upper Extremity forward reach of about 3 inches
排除标准
- •Upper Extremity co-morbidities-pain, arthritis, and other neurological disorders
- •Unable to tolerate electrical stimulation
- •Have implants such as pacemaker, spinal cord or deep brain stimulator
- •Have an elbow contracture of greater than 150 degrees
- •Receiving Botox injections within 3 months
结局指标
主要结局
Kinematic Assessment:Smoothness in 1/s2
时间窗: Change from Baseline Smoothness at 6 weeks
This measure will be collected as the participants performs target reaching out and in movements of the arm. Smoothness will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use.
Kinematic Assessment:Speed in cm/seconds
时间窗: Change from Baseline Speed at 6 weeks
This measure will be collected as the participants performs target reaching out and in movements of the arm. Speed will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use.
Kinematic Assessment:Range of Motion(ROM) in cms
时间窗: Change from Baseline ROM at 6 weeks
This measure will be collected as the participants performs target reaching out and in movements of the arm. ROM will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use.
次要结局
- Modified Ashworth Scale of muscle spasticity (MAS)(Change from Baseline MAS at 6 weeks)
- Wolf Motor Function Test (WMFT)(Change from Baseline WMFT at 6 weeks)
- Fugl-Meyer Upper Extremity(FMA-UE)(Change from Baseline FMA-UE at 6 weeks)
研究者
Kelly Westlake
Associate Professor
University of Maryland, Baltimore