Robotic-Assisted Hand Therapy for Neurorehabilitation in Adults With Hand Sensorimotor Impairments Following a Stroke: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment Upper Extremity (FMA-UE)
研究概览
简要总结
This pilot study will test whether the GRIP program-a soft robotic glove with virtual-reality training-can improve hand and arm function in adults undergoing inpatient rehabilitation after a recent stroke. About 20 participants will be randomly assigned to either the GRIP program or action-observation therapy with education, in addition to usual care. The study will assess motor improvement, safety, and acceptability over approximately six weeks.
详细描述
The goal of this pilot clinical trial is to determine whether the Glove for Rehabilitation and Interactive Practice (GRIP) program can help improve hand and arm movement in adults who have difficulty using their hand after a recent stroke. The GRIP program uses a soft robotic glove and a virtual reality training platform. It is added to the usual rehabilitation care that participants already receive.
The main questions this study aims to answer are:
- Does the GRIP program help improve hand and arm movement?
- Is the GRIP program safe?
- Do participants find the GRIP program acceptable, comfortable, and engaging? (qualitatively).
Researchers will compare the Glove for Rehabilitation and Interactive Practice (GRIP) program with action-observation therapy and education. Action-observation therapy means watching videos of hand movements and then practicing the same movements. Both groups will also receive their usual rehabilitation care. This study will include about 20 adults who are in an inpatient rehabilitation program after a stroke and who have difficulty using their hand.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First unilateral stroke (<6-month post-stroke at enrollment)
- •≥18 years old
- •Hand sensorimotor impairments
- •Able to understand and follow a two-step instruction
- •Admitted to the rehabilitation center and participating in the stroke program
排除标准
- •Severe spasticity (score ≥3 on the Modified Ashworth Scale)
- •Unilateral spatial neglect
- •Moderate to severe hand pain
- •Significant motor impairment of the fingers (active finger flexion/extension less than 10°)
- •Any medical condition that may interfere with participation
结局指标
主要结局
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
时间窗: At enrollment , post-intervention (at 2 weeks), and 1 month follow-up (at 6 weeks)
It is a stroke-specific, performance-based impairment index designed to measure upper extremity motor recovery after stroke.
次要结局
- Action Research Arm Test(At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks))
研究者
Johanne Higgins
Researcher and Professor (School of rehabilitation, Université de Montréal)
Université de Montréal