Robot-Aided Diagnosis, Passive-Active Arm Motor and Sensory Rehabilitation Post Stroke: Aims 2&3
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points
研究概览
简要总结
Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.
详细描述
Sensorimotor impairments following stroke can lead to substantial disability involving the upper extremity. These impairments often involve complex pathological changes across multiple joints and multiple degrees-of-freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. Many potential mechanisms, such as weakness, motoneuronal hyperexcitability, and elevated passive impedance, can contribute and it is currently unclear where to focus treatment. The objectives of this study are to address allocation of therapy resources between the arm and hand and to examine the benefits of combining passive stretching with active movement training.
Aim 1. To compare the efficacy of training the arm versus the hand in promoting upper extremity rehabilitation.
Hypothesis 1: Treating the proximal larger joints in the arm alone will lead to greater improvement than treating the distal hand alone.
Aim 2. To examine the efficacy of combining passive stretching with active (assistive or resistive) training for the shoulder, elbow, wrist, and hand.
Hypothesis 2: Multi-joint intelligent stretching followed by active (assistive or resistive) movement facilitated by use of the IntelliArm arm rehabilitation robot and a Hand rehabilitation robot will improve motor control of the upper extremity more than standard movement therapy alone.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First focal unilateral lesion, ischemic or hemorrhagic
- •Had a stroke 1-12 months prior to enrollment
- •Rated between stages 2-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm and Hand
排除标准
- •Score of less than 22 on the Mini Mental Status Exam
- •Severe pain in the shoulder by a self-rating of 7 out of 10 or greater
- •Severe contracture in the upper extremity
- •Unable to sit in a chair for 3 consecutive hours
- •Unrelated musculoskeletal injuries
- •Poor fit into equipment used in study
- •Botox injection in upper extremity within 4 months
- •Concurrent participation in gait or upper extremity intervention studies
研究组 & 干预措施
The hand robot with passive stretching
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the hand robot.
干预措施: Passive stretching (Other)
The hand robot with passive movement
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the hand robot.
干预措施: Hand robot (Other)
The hand robot with passive stretching
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the hand robot.
干预措施: Hand robot (Other)
The hand robot with passive movement
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the hand robot.
干预措施: Passive movement (Other)
IntelliArm with passive stretching
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.
干预措施: Passive stretching (Other)
IntelliArm with passive stretching
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.
干预措施: IntelliArm (Other)
IntelliArm with passive movement
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.
干预措施: Passive movement (Other)
IntelliArm with passive movement
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.
干预措施: IntelliArm (Other)
结局指标
主要结局
Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points
时间窗: Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention
The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks.
次要结局
- Changes from baseline Fugl-Meyer Upper Extremity at two time points(Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention)
- Changes from baseline Nottingham Sensory Assessment at two time points(Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention)
- Changes from baseline Action Research Arm Test (ARAT) at two time points(Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention)
- Changes from baseline spasticity at two time points(Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention)
- Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at two time points(Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention)
- Changes from baseline Modified Ashworth Scale (MAS) at two time points(Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention)
- Changes from baseline Grip Strength & Pinch Strength at two time points(Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention)
- Changes from baseline relaxation time of the finger flexor muscles at two time points(Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention)
- Changes from baseline range of motion (ROM) at two time points(Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention)
研究者
Li-Qun Zhang
Professor
University of Maryland, Baltimore