Does the Addition of Virtual Reality Training to a Standard Program of Inpatient Rehabilitation Improve Sitting Balance Ability and Function After Stroke? A Blinded Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions
研究概览
简要总结
The purpose of this study is to determine if the addition of 10 to 12 sessions of sitting balance exercises using virtual reality training will provide additional gains in balance ability and function over standard inpatient rehabilitation in stroke patients.
详细描述
Introduction Sitting balance may be affected by stroke, resulting in functional impairment and reduced mobility. Early return of sitting balance predicts greater return of motor function and mobility after stroke. Task-specific therapy is effective but patients must be motivated to perform the exercises repeatedly for the greatest benefit.
Virtual reality training (VRT) allows patients to do exercises while interacting with a video game interface. It is enjoyable and may encourage repetition of therapeutic exercises. Past work in our laboratory showed that standing balance exercises performed with VRT produced additional improvements in gait speed and leg function over traditional inpatient rehabilitation (1). Because of legislative change in Ontario most stroke rehabilitation inpatients today cannot stand independently. There have been no studies on the effect of VRT on sitting balance.
Purpose To assess whether additional sitting balance exercises performed via VRT can improve sitting balance and sitting function (ex. reaching) in stroke rehabilitation inpatients.
Hypothesis The addition of VRT for sitting balance will significantly improve sitting balance and function, beyond the gains realized from traditional inpatient rehabilitation.
Experimental Approach In this blinded randomized control trial funded by the Heart & Stroke Foundation, 76 participants with stroke will be recruited from an inpatient rehabilitation unit. This number will provide enough power to detect a large effect size (0.83) with the primary outcome measure and accounting for a 20% drop-out rate. Individuals who are medically stable and who can sit for at least 20 minutes with or without trunk support but cannot stand independently for more than one minute will be eligible. These criteria will target our selection to those who need to work most on sitting balance. Participants will be randomized into experimental and control groups.
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 in the left or right cortical or subcortical regions
- •medically stable
- •cannot stand independently for >1 minute or cannot stand at all
- •can sit for at least 20 minutes with or without trunk support and can sit for at least 1 minute without trunk support
- •able to provide informed consent
排除标准
- •unstable cardiovascular, respiratory, endocrine, orthopedic or neurological condition that precludes exercise of low to moderate intensity
- •vestibular deficits or vertigo
- •seizure activity in the previous 6 months
结局指标
主要结局
Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions
时间窗: baseline, immediately after 10-12 treatments
assesses static, dynamic and reactional sitting balance
Change in the Function In Sitting Test (FIST) from baseline to 1 month after second assessment
时间窗: baseline,1 month after second assessment
assesses static, dynamic and reactional sitting balance
次要结局
- Change in Limits of stability in sitting (LoS) from baseline to 1 month after second assessment(baseline, 1 month after second assement)
- Change in the Reaching Performance Scale (RPS) from baseline to after 10-12 treatment sessions(baseline, immediately after 10-12 treatments)
- Change in The Motivation for Physical Activity Questionnaire from baseline to after 10-12 treatment sessions(before treatment, immediately after 10-12 treatments)
- Change in the Ottawa Sitting Scale (OSS) from baseline to after 10-12 treatment sessions(baseline, immediately after 10-12 treatments)
- Change in the Ottawa Sitting Scale (OSS) from baseline to 1 month after second assessment(baseline, 1 month after second assement)
- Change in Limits of stability in sitting (LoS) from baseline to after 10-12 treatment sessions(before treatment, immediately after 10-12 treatments)
- Change in the Behavioral Regulation in Exercise Questionnaire (BREQ-2) from baseline to after 10-12 treatment sessions(baseline, immediately after 10-12 treatments)
- Change in Postural sway in sitting from baseline to 1 month after second assessment(baseline, 1 month after second assement)
- Change in Postural sway in sitting from baseline to after 10-12 treatment sessions(baseline, immediately after 10-12 treatments)
- Change in the Reaching Performance Scale (RPS) from baseline to 1 month after second assessment(baseline, 1 month after second assement)
- Change in the Wolf Motor Function Test (WMFT) from baseline to after 10-12 treatment sessions(baseline, immediately after 10-12 treatments)
- Change in the Wolf Motor Function Test (WMFT) from baseline to 1 month after second assessment(baseline, 1 month after second assement)
- Change in The Motivation for Physical Activity Questionnaire from baseline to 1 month after second assessment(baseline, 1 month after second assement)
- Change in the Behavioral Regulation in Exercise Questionnaire (BREQ-2) from baseline to 1 month after second assessment(baseline, 1 month after second assessment)
- Psychosocial Impact of Assistive Devices Scale (PIADS)(1 month after first assement)
- The ability to enroll an average of five new participants a month, to obtain a consent rate of 60% of eligible patients and a rate of protocol violations resulting in noncompliance with VRT of less than 10%.(immediately after 76 participants have finished the protocol and assessments)
研究者
Hillel Finestone
Director of Stroke Rehabilitation Research
Bruyere Research Institute