Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): A Multi-center Comparative Effectiveness Trial of In-home Gamified Constraint-induced Movement Therapy for Rehabilitation of Chronic Upper Extremity Hemiparesis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 9
- 主要终点
- Wolf Motor Function Test
研究概览
简要总结
The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1) traditional clinic-based CI therapy of equal total active therapy duration and (2) a control group equating the dose of in-person therapy. Individuals with chronic stroke will be randomized to one of four different interventions: (1) traditional clinic-based CI therapy (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy (5 therapist/client contact hours in the clinic and 15 hours of independent game play at home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist contact via telerehabilitation (5 therapist/client contact hours in the clinic, 2.6 therapist contact hours via teleconference, and 15 hours of independent game play in the home), and (4) 5 hours of standard occupational therapy (OT) / physical therapy (PT). After 6-month follow-up, individuals assigned to standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone application of the rehabilitation game without additional therapist contact).
详细描述
Detailed study description published in BMC Neurology (2017).
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
- •Males, females, or any gender identity 18 years of age or older
- •Experienced a stroke resulting in mild-to-moderate hemiparesis at least six months prior to enrollment (suggested range of motion (ROM) criteria includes: 45° shoulder abduction and flexion, 20° elbow extension, 20° wrist extension, and 10° extension of thumb and finger)
- •Have preserved ability to comprehend and participate in basic elements of the therapy
排除标准
- •Concurrent participation in other experimental trials for motor dysfunction treatment
- •Receiving Botox therapy currently or in the past 3 months
- •Have medical conditions that would place volunteers at higher risk of adverse events (e.g., renal disease, frailty, pregnancy, dementia, severe pain, end-stage/degenerative diseases)
- •Have received intensive upper-extremity rehabilitation in the chronic phase post-stroke
结局指标
主要结局
Wolf Motor Function Test
时间窗: 0 to 1 months
Assesses the time to complete 15 standardized tasks (e.g., folding a towel, stacking checkers, placing hand on top of a box). Items that cannot be accomplished score 120 seconds. Times are natural log transformed to reflect proportional improvement (approximate % change) and correct for skew. On the log transformed scale, -.22 reflects normal ability, 4.79 = can't accomplish task. For improvement in mean log transformed performance time, -4.79 = best possible improvement, 0 = no improvement, positive scores = worsening. A proportional improvement of 16% (mean log transformed performance time change = -.17) is considered clinically meaningful.
Motor Activity Log Quality of Movement Scale
时间窗: 0 to 1 months
Assessment evaluates the amount and quality of everyday arm use. The scale consists of 28 activities of daily living (e.g., washing hands, drinking from a cup). Participants self-report on an 11-point scale (0-5 with half-point increments, 0=not attempted to 5=attempted with normal movement). The total score on the measure reflects the mean of the individual item scores. A change of 1.0 on the scale is considered clinically meaningful.
次要结局
- Semmes-Weinstein Monofilament Test(0 to 1 months)
- Change in Neuro-Quality of Life (Neuro-QOL)(0 to 1 months)
- Bilateral Activity Monitors(0 to 1 month)
- 9 Hole Peg Test(0 to 1 months)
- Change in Brief Kinesthesia Test (BKT)(0 to 1 months)
研究者
Deborah S Larsen
Professor
Ohio State University