A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Motor Impairment of Wrist and Forearm
研究概览
简要总结
A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program.
详细描述
The objective of this study is to clinically assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program, and investigate the acceptance from patients and therapists. Total of 7 patients will be recruited in this study, all the patients will receive 1.5 hours of standard therapy together with 0.5 hour of robot therapy every day. The robot therapy will be a 30 mins long session for 3 to 5 days per week over a period of six weeks. The study will include forearm pronation-supination and wrist flexion-extension training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sub-acute and chronic stroke patients
- •Able to rest comfortable in training set-up
- •Mini-Mental Status Examination (MMSE) Score (>21)
- •Motor Assessment Scale (Balance sitting >3)
- •Modified Ashworth Scale (Wrist < 2)
排除标准
- •Contractures in affected upper extremity which inhibit movements being tested
研究组 & 干预措施
Robot group
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
干预措施: Robot-assisted therapy for wrist and forearm (Device)
Robot group
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
干预措施: Standard rehabilitation therapy (Other)
结局指标
主要结局
Motor Impairment of Wrist and Forearm
时间窗: Motor impairment of wrist and forearm at week 6
Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject. Procedure: The procedure is done according to the standard guideline of this assessment scale.
次要结局
- Motor Function Assessment of Hand Movement(Motor function of hand function at week 6)
- Spasticity Level of Wrist(Spasticity level of wrist at week 6)
- Forearm's Active Range of Movement(Active range of motion of forearm at week 6)
- Forearm's Passive Range of Motion(Passive range of motion of forearm at week 6)
- Wrist's Passive Range of Motion(Passive range of motion of wrist at week 6)
- Wrist's Active Range of Motion(Active range of motion of wrist at week 6)
研究者
Dr.Yeong Che Fai
Dr.
Universiti Teknologi Malaysia