Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Injury rate
研究概览
简要总结
The goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered virtual Neuromuscular/Dual-Task (vNDT) intervention among healthy U.S. military service members and physically active young adults with a recent concussion.
详细描述
Aim 1. Determine the baseline neuromuscular/dual-task performance characteristics among a sample of active-duty military service members compared to physically active young adult civilians.
The investigators hypothesize that active-duty military service members will have similar baseline gait and dual-task abilities as civilians, demonstrating translation potential between populations.
The investigators also hypothesize that baseline gait and dual-task abilities will be influenced by history of prior mTBI injuries among military Service Members.
Aim 2. Examine the efficacy of a smartphone-based vNDTT intervention to reduce musculoskeletal injury and improve neuromuscular/dual-task performance after a recent mTBI.
The investigators hypothesize that those randomized to the intervention within three weeks of mTBI will have a lower risk of MSK injury in the 3-month period following mTBI, relative to standard-of-care.
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)
盲法说明
The study PI, Co-Is, and the biostatistician will not know group assignments until after the primary analyses are complete.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-40 years of age at the time of enrollment
- •Mild TBI or concussion diagnosis by a physician
- •Confirmed MTBI diagnosis via VA/DOD guidelines at time of enrollment
- •Participation in regular physical activity prior to injury (confirmed via the Global Physical Activity Questionnaire [GPAQ]) (Cleland et al., 2014; Keating et al., 2019)
- •Access to a smartphone for app download
排除标准
- •Moderate or severe TBI
- •Pre-injury neurological disorder
- •Abnormal brain imaging findings (if performed as a part of routine care)
- •Previous TBI (mild/moderate/severe) <12 months prior to enrollment other than the current injury for which they are being seen
研究组 & 干预措施
Standard-of-care
Participants will be provided routine instructions related to physical activity and rehabilitation exercises
Virtual Neuromuscular/Dual-Task Training
The vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks.
干预措施: Virtual Neuromuscular/Dual-Task Training (Behavioral)
结局指标
主要结局
Injury rate
时间窗: 3 months after mTBI
Acute musculoskeletal injury rate
次要结局
- Intervention adherence(Upon enrollment and for the subsequent 8 weeks)
- Sleep quality(During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test)
- Single/dual-task standing and gait(During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test)
- Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference(During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test)
- Dizziness(During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test)
- Anxiety(During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test)