Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Feasibility of integration of two side-by-side BrightBrainer Virtual Reality (BBVR) Rehabilitation Systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center.
研究概览
简要总结
The purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual reality (VR) therapeutic rehabilitative device (BrightBrainerTM) to treat patients with traumatic brain injury (TBI). These patients, service members with TBI, can be both with and without upper limb dysfunction and use uni- and bimanual virtual reality (VR) exercises to improve cognitive and motor function, as well as mood.
详细描述
Bright Cloud International Corp created BrightBrainer, a computerized virtual reality system that provides a combination of cognitive as well as motor skill training in an engaging and repetitive manner [1]. This project objective is to assess the feasibility and clinical benefit of utilizing the BBVR to augment the rehabilitation of service members with TBI. The BrightBrainerTM Virtual Reality (BBVR) Rehabilitation System is unique because it is designed to provide integrative, customized, intensive and self-guided therapy that simultaneously addresses the cognitive, emotive and motor deficits. Early evidence suggests that it has been effective for patients with cognitive deficits as the result of cerebrovascular accident or dementia, but has not yet been evaluated in a therapeutic intervention for patients with TBI. In addition to assessing the system's effect on patient's symptoms, we will also evaluate the feasibility of utilizing this system in a military environment by obtaining feedback from the patients and therapists, regarding system acceptance, reliability and ease of use.
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
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female military health care beneficiaries 18-67 years of age;
- •Presence of TBI (based on standard Veterans Affairs (VA)/ Department of Defense (DoD) criteria);
- •With or without upper extremity dysfunction. Upper extremity dysfunction includes but is not limited to decreased coordination, increased tone, decreased strength, and decreased sensation;
- •Ability to follow study instructions and likely to complete all required visits for the study;
- •Ability to understand spoken and written English;
- •At least 6 weeks post TBI.
排除标准
- •Age less than 18 or greater than 67;
- •Blind or otherwise visually impaired to the extent that lack of sight inhibits utilizing the system;
- •Deafness;
- •Inability to understand or comprehend consenting to the study;
- •Active psychosis, suicidal or homicidal ideations or frequent violent episodes;
- •Currently enrolled in active substance abuse treatment
- •Inability to even minimally operate BBVR controllers.
研究组 & 干预措施
Active Treatment Group
Active treatment will consist of the BrightBrainer Virtual Reality (BBVR) Rehabilitation System therapy intervention (3 sessions per week x 6 weeks). Standard validated outcome measures which assess various domains of function, will be obtained at baseline and then at 3 and 6 weeks for those randomized to the Active Treatment group.
干预措施: BrightBrainer Virtual Reality (BBVR) Rehabilitation System (Device)
Wait-List Control Group
Subjects randomized to the Wait-List Control (WLC) group will wait 3 weeks before beginning the Active Treatment program intervention (3 sessions per week x 6 weeks) using the BrightBrainer Virtual Reality (BBVR) Rehabilitation System. For those randomized to the WLC group, outcome measures will be assessed at baseline, completion of waiting period (3 weeks), then at 3 and 6 weeks after initiating active treatment.
干预措施: BrightBrainer Virtual Reality (BBVR) Rehabilitation System (Device)
结局指标
主要结局
Feasibility of integration of two side-by-side BrightBrainer Virtual Reality (BBVR) Rehabilitation Systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center.
时间窗: At the midpoint (3 weeks)
Clinician Feedback Questionnaire: In order to determine technology feasibility and technology acceptance by the healthcare provider, we will use a subjective evaluation rating questionnaire. The rating will be similar to that used in the subjects' questionnaire, however, questions will differ.
Feasibility of integration of two side-by-side BBVR systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center.
时间窗: At the endpoint (6 weeks)
Clinician Feedback Questionnaire: In order to determine technology feasibility and technology acceptance by the healthcare provider, we will use a subjective evaluation rating questionnaire. The rating will be similar to that used in the subjects' questionnaire, however, questions will differ.
次要结局
- Subject and clinician acceptance of the BBVR system (ease of use, ease of set up and monitoring, ease of data report production, ease of monitoring two subjects simultaneously)(At the endpoint (6 weeks) of the active treatment for every participant.)
- Participant cognitive performance(Change in performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.)
- Participant motor function (range of motion, strength, and coordination) - Fugl-Meyer Assessment(Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.)
- Participant motor function - Jebsen Hand Function Test(Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.)
- Participant motor function - Box and Blocks Test(Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.)
- Participant functional performance(Change in functional performance over the course of active treatment.)
- Reliability of the BBVR technology when deployed in a clinical setting(Throughout the duration of the study - expected to last one year.)
- Participant symptoms(Change in symptom reporting from baseline to of the wait-list (for the wait-list control group only), midpoint (3 weeks) of active therapy, and end point (6 weeks) of active treatment.)