Dual-Task Exercise for Mild Traumatic Brain Injury (mTBI)

NCT06037603 | Completed DMC

• 1 other identifier: UNLV-2023-245
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators previously developed a virtual 14-day dual-task walking exercise program and tested its feasibility with individuals with mild traumatic brain injury (mTBI) history. The investigators will test the feasibility and efficacy of a mobile app-version (Uplode) of the same 14-day exercise program (Brain \& Walk Exercise Every Day \[BraW-Day\]), on cognition, sensorimotor, and other functions in a group of voluntary young adults with an mTBI between last three months to two years, including student athletes, Veterans, and ethnic minorities.

Conditions

TBI (Traumatic Brain Injury); Brain Concussion; Clinical Trial; Rehabilitation; Cognition; Psychosocial Functioning; Walking; Vision, Ocular; Mobile Application; Saliva; microRNA; Exercise

Keywords

dual-task exercise; mobile app-guided; home-based; mild traumatic brain injury (mTBI); cognitive function; physical function; psychosocial function; salivary exosomal microRNA

Outcome Measures

Primary Outcomes (6)

• Change in cognitive function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)

  The CNS-Vital Signs Test is a computerized test of cognitive functioning with good-to-excellent reliabilities (most r's \> 0.8) in its different sub-tests. It will measure comprehensive neurocognitive function, including memory, attention psychomotor speed, reaction time, and cognitive flexibility. Higher scores mean better cognitive functioning outcomes. The CNS-Vital Signs Test standard scores and percentile ranks are auto-scored using an algorithm based on a normative data set of 1600+ subjects, ranging from Ages 8 - 90. Standard scores \> 110 or percentile scores \> 74 indicate high function and high capacity, and standard scores \< 70 or percentile scores \< 2 indicate deficit and impairment likely.

  45 days

• Change in psychosocial function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)

  The Quality of Life in Neurological Disorders Item Bank will be used to assess depressive, anxious symptoms, fatigue, sleep disturbances, and other functions that may be affected by chronic mTBI. Each domain measure has undergone rigorous qualitative and psychometric evaluation and refinement through numerous clinical studies, so the measures could provide efficient, precise, valid, and responsive indicators of a person's health status. Higher scores mean better psychosocial functioning outcomes. The Quality of Life in Neurological Disorders Item Bank scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment Scores 2.0 SD or more worse than the mean = severe symptoms/impairment

  45 days

• Change in sensorimotor function - vision from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)

  Rapid eye movement by EyeLink 1000 Plus System (SR Research)

  45 days

• Change in sensorimotor function - walking from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)

  Walking features and balance by mobile health application for walking balance (mHealth-WB)

  45 days

• Change in sensorimotor function - gait from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)

  3-dimensional kinematic and kinetic gait analysis (lab-based approach)

  45 days

• Acceptability, feasibility of the BraW-Day program on Uplode app

  Semi-structured interview (max. 20 mins) based on components of the System Usability Scale focusing on acceptability, feasibility, and barriers and facilitators for the BraW-Day exercise program on the Uplode app. System Usability Scale scores are standardized on a 0-100 scale, Higher scores mean better acceptability of an app, so in this study, the Uplode app.

  15 days

Secondary Outcomes (1)

• Change in salivary exosomal microRNA from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)

  45 days

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will be asked to visit the UNLV study site three times to evaluate baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).

Behavioral: Brain & Walk Exercise Every Day (BraW-Day)

Wait-list Control

ACTIVE COMPARATOR

The wait-list control group will be will be asked to visit the UNLV study site four times to evaluate pre-baseline (T0), baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).

Behavioral: Brain & Walk Exercise Every Day (BraW-Day)

Interventions

Brain & Walk Exercise Every Day (BraW-Day) BEHAVIORAL

The Brain \& Walk Exercise Every Day (BraW-Day) program comprises 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).

Intervention; Wait-list Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female adults aged 18-40 years
• reporting a recent history of mTBI (3 months - 2 years) based on the Ohio State University TBI Identification Method (OSU TBI-ID)
• understanding the protocol, and
• capable of participating in the full BraW-Day program and completing assessments

You may not qualify if:

• Those with other active medical disease or such history
• psychiatric disturbance, substance abuse, learning disorder, or attention deficit hyperactivity disorder (ADHD)
• any impairments that may prevent the participant from completing the tests safely, or
• currently on prescribed medications
• involved in any type of legal action related to the mTBI

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154-3018, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Motor Activity

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Non-blinded randomized trial with a wait-list control design
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-blinded randomized trial with a wait-list control design

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: September 14, 2023
• Study Start: March 6, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

US (1)