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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Concussion
• Intervention / Treatment: Behavioral: Virtual Neuromuscular/Dual-Task Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Makenna Hemmerle, MS; Phone Number: 702-777-1502; Email: ConcussionResearch@CUAnschutz.edu
• Study Contact Backup: Name: Lindsey Kemp, BS; Phone Number: 702-777-1502; Email: ConcussionResearch@CUAnschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Denver
      • Contact: David R Howell, PhD; Phone Number: 720-777-1502; Email: ConcussionResearch@cuanschutz.edu
      • Contact: Makenna Hemmerle, MS; Phone Number: 7207771502; Email: ConcussionResearch@cuanschutz.edu
  • Texas
    • Fort Sam Houston, Texas, United States, 78236
      • Recruiting
      • Brooke Army Medical Center
      • Contact: William T Davis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Standard-of-care; Participants will be provided routine instructions related to physical activity and rehabilitation exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injury rate	Acute musculoskeletal injury rate	3 months after mTBI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention adherence	Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions	Upon enrollment and for the subsequent 8 weeks
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Binghamton University; Brooke Army Medical Center
• Investigators: Principal Investigator: David R Howell, PhD, University of Colorado School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Reinjuries
• Other Study ID Numbers: 22-1352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Unidentified/blinded IPD data may be made available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No