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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05594225
• Collaborator: Brooke Army Medical Center (U.S. Fed), Binghamton University (Other)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 19.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Concussion	Behavioral: Virtual Neuromuscular/Dual-Task Training	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 mTBIParticipants 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
• Masking: Single (Outcomes Assessor)
• Masking Description: The study PI, Co-Is, and the biostatistician will not know group assignments until after the primary analyses are complete.
• Primary Purpose: Treatment
• Official Title: Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Aug 30, 2024
• Anticipated Study Completion Date: Aug 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Injury rate [3 months after mTBI]

   Acute musculoskeletal injury rate

Secondary Outcome Measures

1. Intervention adherence [Upon enrollment and for the subsequent 8 weeks]

   Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions

2. 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]

   Patient-Reported Outcomes Measurement Information System (PROMIS) global questionnaire

3. Sleep quality [During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test]

   Participants will complete the Pittsburgh Sleep Quality Inventory

4. Dizziness [During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test]

   Participants will complete the Dizziness Handicap Inventory

5. Anxiety [During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test]

   Participants will complete the General Anxiety Disorder - 7 scale

6. Single/dual-task standing and gait [During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test]

   Participants will perform walking trials under single and dual-task conditions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18-35 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Colorado, Denver
• Brooke Army Medical Center
• Binghamton University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT05594225
• Other Study ID Numbers: 22-1352
• First Posted: Oct 26, 2022
• Last Update Posted: Nov 3, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Reinjuries

Study Results

No Results Posted as of Nov 3, 2022