Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk

Brain Concussion Clinical Trial

Official title:

Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05594225
• Other study ID #: 22-1352
• Status: Recruiting
• Phase: Phase 1
• Start date: August 23, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: October 2023
• Source: University of Colorado, Denver
• Contact: Makenna Hemmerle, MS
• Phone: 702-777-1502
• Email: ConcussionResearch[@]CUAnschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Binghamton University, Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injury rate	Acute musculoskeletal injury rate	3 months after mTBI
Secondary	Intervention adherence	Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions	Upon enrollment and for the subsequent 8 weeks
Secondary	Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference	Patient-Reported Outcomes Measurement Information System (PROMIS) global questionnaire	During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Secondary	Sleep quality	Participants will complete the Pittsburgh Sleep Quality Inventory	During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Secondary	Dizziness	Participants will complete the Dizziness Handicap Inventory	During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Secondary	Anxiety	Participants will complete the General Anxiety Disorder - 7 scale	During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Secondary	Single/dual-task standing and gait	Participants will perform walking trials under single and dual-task conditions	During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test