NCT01794585已完成不适用
Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change from Baseline on Community Balance and Mobility (CB&M)
研究概览
简要总结
The purpose of this study is to evaluate the effectivenes of a home-based physical therapy program designed to improve balance following traumatic brain injury by incorporating the use of a virtual reality system.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has sustained a documented TBI that required an inpatient rehabilitation program;
- •is at least one year post TBI;
- •is at least 18 and no more than 64 years of age at the time of enrollment;
- •is English or Spanish speaking
- •is at least three months beyond completion of formal PT, including acute inpatient rehabilitation, outpatient and home-based therapy;
- •provides written medical clearance for participation in an in-home balance exercise program;
- •ambulates independently within the home (with assistive devices and/or orthotics as needed);
- •has active range of motion of bilateral upper extremities of at least 90 degrees of abduction to allow for control of the VR system;
- •completes a 15 minute trial using a VR system in the absence of a negative physical or behavioral reaction;
- •self-reports ongoing balance deficits and demonstrate such deficits by scoring at or below one standard deviation above the mean (75 or below) on the CB&M; and
- •provides informed consent, or has a guardian available to provide consent.
排除标准
- •has a history of another medical illness or neurological disorder which may affect balance;
- •has experienced a seizure within the last year;
- •has a history of psychiatric disorder requiring hospitalization;
- •is currently participating in another RCT;
- •is currently using VR technology to address specific balance goals;
- •is unable to travel to Craig for assessments throughout the study period;
- •is unable to communicate effectively to complete standardized assessments;
- •has cognitive impairment that precludes completion of baseline testing;
- •is unavailable to participate in 12 continuous weeks of therapy;
- •has no access to television able to connect to VR-gaming system; and
- •reports inadequate space required for VR-gaming system sensors.
研究组 & 干预措施
Standard Exercise
Active Comparator
干预措施: Standard Exercise (Behavioral)
Virtual Reality Based Exercise
Experimental
干预措施: Virtual Reality Based Exercise (Behavioral)
结局指标
主要结局
Change from Baseline on Community Balance and Mobility (CB&M)
时间窗: Baseline, 6-weeks, 12 weeks, 24weeks
Specifically developed to assess balance function for individuals with TBI. Includes 13 balance based activites such as single leg standing, tandem walking, hopping, running, descending stairs.
次要结局
- Change from Baseline on Balance Evaluation Systems Test (BESTest)(Baseline, 6weeks, 12weeks, 24weeks)
- Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC)(Baseline, 6weeks, 12weeks, 24weeks)
- Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O)(Baseline, 6 weeks, 12weeks, 24weeks)
研究者
研究点 (2)
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