Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies for Post-TBI Return-to-duty (RTD) Decision Making (Praxis)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Perceived usability of the Praxis system measured by the System Usability Scale (SUS)
研究概览
简要总结
The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member (SM) population after mild Traumatic Brain Injury (mTBI).
The main questions this comparative pilot study aims to answer are:
- Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI?
- Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery?
Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation including:
- gaze stabilization
- dual-task balance training
- spatial navigation
- agility training
Data from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group.
Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation.
详细描述
This study considers Praxis: a portable testbed with low-cost wearable sensors and a mixed reality environment to deliver effective multisensory rehabilitation exercises with military face-validity. Through a small comparative pilot study, the investigators plan to provide evidence for future multi-center randomized trials (MCRTs) to show that progress in these multisensory exercises correlates with established military readiness assessments; and that the improvements in functional performance in response to multisensory rehabilitation strategies is associated with changes in brain activity.
In preparation for an MCRT, the investigators will conduct a pilot study to examine and settle the issues of feasibility and effectiveness of protocol implementation in accordance with best practices. In this study, we:
- deliver a well-defined rehabilitation strategy via the Praxis system to the enable the patient to practice challenging rehabilitation tasks,
- assess changes in neurophysiological activity via resting state functional magnetic resonance imaging (rs-fMRI) over time in relation to the intensity of the rehabilitation strategy, and
- assess sensitive behavioral outcome measures that monitor the SM's functional gains over time via a battery of military-relevant tasks.
Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation:
- gaze stabilization
- dual-task balance training
- spatial navigation
- agility training
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Praxis Group:
- •Participating in the SPaR Program
- •18-50 years old
- •Have a self-reported or clinician-confirmed mTBI
- •Have continued complaints of dizziness/imbalance
- •Are right-handed as determined by the Edinburgh Handedness Inventory-Short Form
- •Inclusion Criteria for Control Group:
- •Participating in the SPaR Program
- •18-50 years old
- •No complaints of dizziness/imbalance
排除标准
- •Having impaired mental capacity (e.g., altered capacity due to administration of any mind-altering substances or stress/life situations)
- •Displaying behavior that would significantly interfere with validity of data collection or safety during the study
- •Reporting significant pain during the evaluation (7/10 by patient subjective report)
- •Being pregnant (balance considerations)
- •Being unable to abstain from the use of alcohol and medications that might impair participant's balance or cerebral blood flow for 24 hours in advance of testing
- •Being mixed or left-handed as determined by the Edinburgh Handedness Inventory-Short Form for the Praxis group undergoing rs-fMRI.
研究组 & 干预措施
Praxis
Fifteen SMs with post-acute mTBI and residual dizziness/imbalance complaints from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will receive 4 weeks of Praxis intervention (45 minutes, 5 days per week)
干预措施: Praxis (Device)
Control
Fifteen SMs without dizziness/imbalance complaints from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will receive 4 weeks of supervised cardiovascular activity (45 minutes, 5 days per week)
干预措施: Supervised cardiovascular exercise (Behavioral)
结局指标
主要结局
Perceived usability of the Praxis system measured by the System Usability Scale (SUS)
时间窗: Subjects will be tested after a 4-week intervention period
The System Usability Scale (SUS) provides an industry-standard reliable tool for measuring the usability of a system (unit of measurement: number, 0-100). This scale relates to the usability (e.g., feasibility) of the prototype device, and is not a health outcome.
次要结局
- Change in Dizziness Handicap Inventory (DHI) score(Subjects will be tested before and after a 4-week intervention period)
- Change in Pittsburgh Sleep Quality Index (PSQI) score(Subjects will be tested before and after a 4-week intervention period)
- Change in Generalized Anxiety Disorder scale (GAD-7) score(Subjects will be tested before and after a 4-week intervention period)
- Change in Post-Traumatic Stress Disorder Check List - Military Version (PCL-M) score(Subjects will be tested before and after a 4-week intervention period)
- Change in Vestibular Activities Avoidance Instrument-9 (VAAI-9) score(Subjects will be tested before and after a 4-week intervention period)
- Change in Headache Impact Test-6 (HIT-6) score(Subjects will be tested before and after a 4-week intervention period)
- Change in Santa Barbara Sense of Direction Scale (SBSOD) score(Subjects will be tested before and after a 4-week intervention period)
- Change in time required to perform 300-yard shuttle run (single- and dual-task)(Subjects will be tested before and after a 4-week intervention period)
- Change in perceived fogginess(Subjects will be tested before and after a 4-week intervention period)
- Change in score for 4-Item Hybrid Assessment of Mobility for mTBI (HAM-4-mTBI)(Subjects will be tested before and after a 4-week intervention period)
- Change in time required to perform POrtable WARrior Test Of Tactical AgiLity (POWAR-TOTAL) (single- and dual-task)(Subjects will be tested before and after a 4-week intervention period)
- Change in time required to perform 5-10-5 shuttle run(Subjects will be tested before and after a 4-week intervention period)
- Change in Vestibular/Ocular Motor Screening (VOMS) total symptom score(Subjects will be tested before and immediately after intervention)
- Compliance with 20-minute daily dose of gaze stability exercises(Acquired every 24 hours during the 4-week intervention period)