University of Nevada, Las Vegas
Las Vegas, Nevada, 89154-3018, United States
NCT Number: NCT07599475
This research study examines recovery after a sports-related concussion or mild head injury. Many athletes experience lingering problems with thinking, balance, and mood months after a concussion.
We are testing a new home-based program called BraW-Day™ (Brain & Walk Exercise Every Day). This 14-day program uses a mobile app on your smartphone and combines simple brain exercises (like counting backwards) with walking exercises. The idea is that doing these tasks together may help your brain and body recover more effectively.
What You'll Do:
* Two in-person visits at UNLV (baseline and after 14 days) for assessments * Daily 15-minute exercises at home using the BraW-Day app * Provide a small saliva sample for biomarker testing * Complete brief questionnaires about your symptoms and health
Potential Benefits:
You may experience improvements in thinking, balance, or mood. Even if you don't benefit directly, your participation will help researchers understand how to better support athletes recovering from concussion.
Who Can Join:
* Ages 18-40 * Had a sports-related concussion or mild head injury within the past 3-12 months * Have a smartphone and can safely do light walking and simple tasks
This study is registered at ClinicalTrials.gov and approved by the UNLV Institutional Review Board to protect your safety and rights.
Trial opening soon.
Get Notified18 year–40 year
All sexes
Interventional
Not applicable
Las Vegas, Nevada, 89154-3018, United States
Background and Rationale:
Mild traumatic brain injury (mTBI) and sports-related concussion affect thousands of athletes annually and often result in persistent cognitive, physical, and physiological symptoms that can extend months beyond the initial injury. Current recovery protocols typically focus on single-domain interventions (cognitive training alone or physical rehabilitation alone). Emerging evidence suggests that integrated, dual-task interventions-combining cognitive and physical exercise simultaneously-may enhance neuroplasticity and accelerate functional recovery by engaging multiple neural systems.
Study Rationale:
This feasibility study evaluates a novel mobile dual-task intervention (BraW-Day™) designed specifically for athletes recovering from mTBI/concussion. The intervention combines cognitive challenges with structured walking exercises, administered through a smartphone application for accessibility and adherence. We hypothesize that this integrated approach will improve cognitive function, physical balance, and physiological markers (heart rate variability) while demonstrating feasibility for home-based, technology-enabled delivery.
Intervention Description:
BraW-Day™ is a 14-day home-based mobile app intervention combining:
Each session is 15 minutes and performed daily for 14 consecutive days. The app provides real-time feedback and allows users to pause or adjust intensity as needed.
Study Design:
This is a single-arm feasibility study with pre-post assessment design. Participants complete two in-person study visits (baseline and post-intervention) separated by 14 days of home-based intervention.
Assessments:
Primary Outcomes:
Feasibility metrics including recruitment rate, retention rate (completion of 14-day intervention), adherence to daily exercises, and safety.
Secondary Outcomes:
Changes in cognitive function, symptom severity, balance/gait, heart rate variability, and biomarker expression from baseline to post-intervention. User feedback on intervention acceptability and recommendations for future implementation.
Population:
Athletes aged 18-40 who sustained a sports-related concussion or mild TBI within 3-12 months prior to enrollment. Participants must be able to safely perform light physical activity and have consistent smartphone access.
Study Duration:
2 weeks of active intervention per participant; approximately 6.5-7 hours total time commitment.
Significance:
This study addresses a critical gap in mTBI recovery by evaluating an accessible, scalable intervention that integrates cognitive and physical rehabilitation. If feasible and effective, BraW-Day™ could provide athletes with an evidence-based home-based tool to optimize recovery and reduce persistent post-concussion symptoms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants engage in a 14-day home-based mobile dual-task intervention using the Uplode smartphone application. Each daily session lasts 15 minutes and combines two concurrent components: (1) Walking exercises-progressive heel-to-toe walking alternating with figure-8 walking patterns; and (2) Cognitive tasks-five-minute brain exercises (e.g., counting backwards, working memory challenges) performed simultaneously with walking. On Day 8, cognitive task difficulty increases to provide progressive challenge. The app delivers daily reminders, tracks completion, and provides real-time feedback. Optional guided breathing exercises (5-10 minutes) are available for relaxation and sleep support. Participants self-pace the exercises and can pause the app if needed. The intervention is designed to engage multiple neural systems (motor and cognitive) simultaneously to enhance neuroplasticity and facilitate recovery from concussion/mild traumatic brain injury.
Time frame: Day 15
Semi-structured interview (max 20 minutes) assessing acceptability, feasibility, usability, and barriers/facilitators for the BraW-Day™ exercise program on the Uplode app. System Usability Scale (0-100 scale; higher scores indicate better acceptability).
Time frame: Day 0 & Day 15
Neuro-QOL Cognitive Function Short Form assessing difficulty with memory, attention, executive function, and processing speed (e.g., tracking time, financial document accuracy, following complex instructions). Raw scores converted to T-scores (mean 50, SD 10); higher scores indicate better cognitive function.
Time frame: Day 0 & Day 15
Neuro-QOL Depression Short Form assessing depressive symptoms. T-scores (mean 50, SD 10); higher scores indicate worse depressive symptoms.
Time frame: Day 0 & Day 15
Neuro-QOL Anxiety Short Form assessing anxiety symptoms. T-scores (mean 50, SD 10); higher scores indicate worse anxiety.
Time frame: Day 0 & Day 15
Neuro-QOL Fatigue Short Form assessing fatigue severity and impact. T-scores (mean 50, SD 10); higher scores indicate worse fatigue.
Time frame: Day 0 & Day 15
Neuro-QOL Sleep Disturbance Short Form assessing sleep quality and disturbance. T-scores (mean 50, SD 10); higher scores indicate worse sleep disturbance.
Time frame: Day 0 & Day 15
Neuro-QOL Emotional and Behavioral Dyscontrol Short Form assessing emotional regulation and impulsivity. T-scores (mean 50, SD 10); higher scores indicate worse dyscontrol.
Time frame: Day 0 & Day 15
Neuro-QOL Ability to Participate in Social Roles and Activities Short Form assessing functional limitations in social and occupational roles. T-scores (mean 50, SD 10); higher scores indicate better participation.
Time frame: Day 0 & Day 15
Neuro-QOL Positive Affect and Well-Being Short Form assessing psychological well-being and positive emotions. T-scores (mean 50, SD 10); higher scores indicate better well-being.
Time frame: Day 0 & Day 15
Neuro-QOL Stigma Short Form assessing felt and internalized stigma related to neurological condition. T-scores (mean 50, SD 10); higher scores indicate greater stigma.
Time frame: Day 0 & Day 15
mHealth Walking Balance (mHealth-WB) mobile application assessment of walking features and dynamic balance during gait.
Time frame: Day 0 & Day 15
EyeLink 1000 Plus System (SR Research) rapid eye movement and oculomotor function assessment.
Time frame: Day 0 & Day 15
8-minute seated rest recording measuring cardiac autonomic nervous system function. Higher HRV indicates better parasympathetic tone and cardiovascular function.
Time frame: Day 0 & Day 15
Saliva samples (1-2 mL) analyzed for exosomal microRNA biomarkers as indicators of neurodegeneration and functional recovery. Samples stored at -70°C for future characterization.
Contact information is provided by the study sponsor or research team.
Hyunhwa Lee
Other
Boosting Brain and Balance: A Mobile Dual-Task Intervention for Athletes With Concussion and Mild Traumatic Brain Injury (mTBI)
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