Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE)
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. 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 the VirTele system for people who have suffered a stroke who are no longer receiving rehabilitation services The VirTele system allows upper limb rehabilitation using exergames with ongoing off-line monitoring combined with online monitoring and coaching based on the self-determination theory.
详细描述
More specifically, the primary objective of the RCT is to provide preliminary evidence regarding efficacy of the VirTele program for upper limb motor control recovery in chronic stroke. Secondary objectives are to: i. Determine the effect of the VirTele program on upper limb function, quality of life and motivation; ii. Determine the feasibility of using the VirTele program with users at home (e.g. adherence, safety, technical difficulties, facilitators and barriers); iii. Explore the role that shared decision-making and empowerment play in exercise program adherence and progression, and in behavior modification for upper-limb use.
This study will also provide evidence of feasibility for conducting a larger-scale RCT comparing different technologies and interventions for chronic stroke rehabilitation.
A single-blind (evaluator) two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 8-week training with the VirTele system.i.e. treatment group or (2) 8-week written home exercise program provided by a clinician (GRASP), 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 2-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
- •No longer receiving rehabilitation services;
- •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 limiting movements for the game;
- •Previous upper limb impairment limiting potential recovery.
结局指标
主要结局
Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE)
时间窗: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Upper limb motor control is assessed using a valid and reliable outcome, scores between 0-66, higher scores indicating better motor control. measure consisting of tasks to be performed by the participant
次要结局
- Change from Baseline in Upper limb function at 8 weeks Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use(baseline and eight weeks after intervention, as well as 1 and 2 month follow up)
- Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test(baseline and eight weeks after intervention, as well as 1 and 2 month follow up)
- number of sessions (feasibility)(8 weeks (ongoing))
- duration of sessions (Feasibility)(8 weeks (ongoing))
- Amount of time spent on the actual exe games (moving the arm)(8 weeks (ongoing))
- Frequency of on-line consultations with therapist(8 weeks (ongoing))
- duration (minutes) of on-line consultations with therapist(8 weeks (ongoing))
- adverse event (counts)(8 weeks (ongoing))
- falls (count)(8 weeks (ongoing))
- adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)(8 weeks (ongoing))
研究者
Dahlia Kairy
Associate Professor
Université de Montréal