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

RECRUITING

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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.

Conditions:

Brain Concussion

Study Start (Actual) 2023-08-23

Primary Completion (Estimated) 2025-01-30

Study Completion (Estimated) 2025-01-30

Enrollment (Estimated) 88

Study Type INTERVENTIONAL

Phase PHASE1

Locations:

📍 Aurora, Colorado, United States

📍 Fort Sam Houston, Texas, United States

Eligibility Criteria

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

Ages Eligible for Study: 18 Years to 40 Years (ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-10-21
First Submitted that Met QC Criteria2022-10-21
First Posted2022-10-26

Study Record Updates

Last Update Submitted that Met QC Criteria2023-10-18
Last Update Posted2023-10-19
Last Verified2023-10