Clinical trial NCT05594225: Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
Official title: Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Brain Concussion
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Brooke Army Medical Center
name: Binghamton University
First posted: 2022-10-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will enroll and undergo initial testing within three weeks of mTBI, be randomized to an 8-week vNDTT or standard-of-care intervention, return for post-intervention testing, and be monitored for subsequent MSK injuries in the three months after mTBI
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The investigators also hypothesize that those randomized to the intervention within three weeks of mTBI will have better post-intervention gait and dual-task performance than those assigned to standard-of-care, despite similar baseline performance.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Injury rate
timeFrame: 3 months after mTBI
Secondary outcomes:
measure: Intervention adherence
timeFrame: Upon enrollment and for the subsequent 8 weeks
measure: Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference
timeFrame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
measure: Sleep quality
timeFrame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
measure: Dizziness
timeFrame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
measure: Anxiety
timeFrame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
measure: Single/dual-task standing and gait
timeFrame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: University of Colorado School of Medicine
name: David R Howell, PhD
role: PRINCIPAL_INVESTIGATOR
References: