Maximizing Post-stroke Upper Limb Rehabilitation Using a Novel Telerehabilitation Interactive Virtual Reality System in the Patient's Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change from Baseline in Upper limb motor control at 4 weeks
研究概览
简要总结
Stroke is a leading cause of death and long-term disability worldwide and its incidence is on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a significant long-term impact on activities of daily living, leisure activities and work. The capacity for recovery following a stroke depends on several factors, including the extent of the initial neurological damage, spontaneous recovery and rehabilitation, with possible recovery even years after the stroke. Unfortunately, accessibility of much needed rehabilitation services poststroke often remains limited, both in terms of intensity and duration, as reported in a recent report on post-stroke rehabilitation services in Quebec (Richard, 2013) Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for upper limb training post-stroke when rehabilitation services are not available. Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends home-based patient monitoring be used when frequent monitoring is needed and face-to-face visits are not available. Hence, The investigators have developed and propose to examine the use of a TR system that allows upper limb rehabilitation with ongoing off-line monitoring, to be used after usual poststroke rehabilitation is completed and services are no longer offered.
详细描述
More specifically, the objective of the proposed study is to assess the impact, in terms of motor recovery, function,quality of life, compliance, safety and cost, of a novel, patient-centered home-based tailored TR program using an affordable virtual reality system for upper-limb rehabilitation post-stroke. Such a system, combined with remote off-line monitoring could allow patients to take charge and pursue their rehabilitation beyond current services, maximizing their potential for recovery.
A single-blind two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 4-week training with home-based tele-rehabilitation (TR) system (see intervention below).i.e. treatment group or (2) 4-week written home exercise program provided by a clinician, i.e. exercise control group.
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
- •Ischemic or hemorrhagic stroke (does not have to be a first time stroke);
- •Mild to moderate upper limb impairment (score 3-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
- •At least 6 months post stroke;
- •No longer receiving rehabilitation services; and (5) living in an area where high speed Internet access is available.
排除标准
- •Being medically unstable;
- •Severe cognitive or communication deficits;
- •Visual impairments;
- •Severe balance deficits limiting sitting safely independently;
- •Shoulder pain;
- •Previous upper limb impairment limiting potential recovery.
结局指标
主要结局
Change from Baseline in Upper limb motor control at 4 weeks
时间窗: baseline and four weeks after intervention
as measured using the Fugl-Meyer Assessment-UE (FMA-UE).
次要结局
- Change from Baseline in quality of life at 4 weeks(At intake into the study ( post-stroke; chronic phase) and four weeks after intervention)
- Change from Baseline in Upper limb motor control at 4 weeks(At intake into the study ( post-stroke; chronic phase) and four weeks after intervention)
- Change from Baseline in Upper limb function at 4 weeks(At intake into the study ( post-stroke; chronic phase) and four weeks after intervention)
研究者
Dahlia Kairy
Professor
Université de Montréal