Robotic Therapy Early After Stroke Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
Weakness and impairment of the upper limb is a common contributing factor to post stroke disability. Specially designed robotic systems have been developed to try to improve this. The investigators already know that their use helps improve limb function after stroke when it has been present for many months. The investigators do not know whether they can help early after stroke and enhance recovery of limb function, and perhaps prevent weakness becoming chronic.
The investigators plan a randomised controlled blinded study to explore the benefits of robot assisted therapy early after stroke in 80 stroke survivors. Participants will be randomised by 7 days after stroke to standard care or to robotic therapy (40 participants per study group).
Standard of care will be rehabilitation therapy according to local guidelines delivered by NHS multidisciplinary team.
Robotic therapy sessions lasts approximately one hour and consists of a series of tasks in first the unimpaired then impaired limb. The robotic-assisted therapy will consist of a series of taks including circle-drawing, reaching targets and holding/moving against moderate resistance. Twelve sessions of therapy within the first 4 weeks after randomisation will be delivered. This study will take 3 years to complete.
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
- •Aged > 18 years
- •Confirmed diagnosis of stroke
- •Randomisation by seven days
- •Upper limb impairment, defined as a measurable upper limb impairment on the NIHSS and a baseline upper limb FuglMeyer score of <50 at randomisation
- •Able to comply with the requirements of the protocol
排除标准
- •Other significant upper limb impairment e.g. fixed contracture, fracture, frozen shoulder, severe arthritis, amputation.
- •Diagnosis likely to interfere with rehabilitation or outcome assessments such as registered blind or terminal illness.
- •Participation in other stroke rehabilitation trial.
结局指标
主要结局
Feasibility
时间窗: One month
Defined as the proportion of individuals randomised to robotic intervention who complete 12 sessions of Robotic therapy. Will serve as a coprimary endpoint.
Fugl-Meyer score therapy.
时间窗: One month
次要结局
- Fugl-Meyer score.(Day 90)
- Action Research Arm Test(Day 90)
- Modified Rankin scale score(DAy 90)
- Stroke Impact Scale(Day 90)
- Barthel index(Day 90)
- NIHSS(Day 90)
研究者
Dr Jesse Dawson
Clinical Senior Lecturer in Medicine / Honorary Consultant
University of Glasgow