Boosting Brain and Balance: A Mobile Dual-Task Intervention for Athletes With Concussion and Mild Traumatic Brain Injury (mTBI)
| Registry | NCT07599475 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 20 (Estimated) |
| Sponsor | Hyunhwa Lee (Other); collaborators: University of Nevada, Las Vegas |
| Conditions | Mild Traumatic Brain Injury (mTBI), Sports-related Concussion, Heart Rate Variability (HRV), Walking, Oculomotor, Saliva, Exosomal microRNA, Cognitive Function |
| Interventions | Home-Based Mobile Dual-Task Intervention (BraW-Day™) (Behavioral) |
| Dates | start 2026-05-15 (estimated), primary completion 2027-04-30 (estimated), completion 2027-04-30 (estimated), first posted 2026-05-20, last updated 2026-05-20 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Mild Traumatic Brain Injury (mTBI) All trials for Sports-related Concussion All trials of Home-Based Mobile Dual-Task Intervention (BraW-Day™)
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.
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:
* Walking exercises: Progressive heel-to-toe walking and figure-8 walking patterns
* Cognitive tasks: Five-minute brain exercises (number counting, working memory tasks) performed concurrently with walking
* Optional breathing exercises for relaxation and sleep support
* Daily reminders and progression tracking via the Uplode mobile application
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:
* Cognitive function: Neuro-QoL cognitive assessment
* Lifetime trauma history: PhenX Lifetime Trauma and Victimization History Instrument
* Physiological markers: Heart rate variability (HRV) measured via wearable sensors
* Physical function: Eye-tracking (EyeLink) for oculomotor control; walking assessment using mobile sensors for movement analysis
* Symptom severity: Ohio State University TBI Identification Interview, Rivermead Post-Concussion Symptoms Questionnaire, Neurobehavioral Symptom Inventory
* Biological markers: Saliva collection for exosomal microRNA analysis to assess recovery at the molecular level
* User experience: Semi-structured interview regarding intervention feasibility, acceptability, and perceived benefits
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 14-Day BraW-Day™ Intervention | Experimental | Behavioral: Home-Based Mobile Dual-Task Intervention (BraW-Day™) | Participants receive a 14-day home-based mobile dual-task intervention (BraW-Day™) delivered via the Uplode smartphone application. The intervention combines daily 15-minute sessions of heel-to-toe and figure-8 walking with concurrent cognitive tasks (e.g., counting backwards, working memory exercises). Cognitive task difficulty increases on Day 8. Optional guided breathing exercises are available via the app. Participants complete assessments at baseline (Day 0) and post-intervention (Day 15). |
Sex: All, ages: 18 Years to 40 Years
Inclusion Criteria: * Adults aged 18 to 40 years * Self-reported history of sports-related concussion (SRC) or mild traumatic brain injury (mTBI) within the past 3 to 12 months * Meets criteria for mTBI based on a standardized screening method (e.g., Ohio State University TBI Identification Method) * Able to safely participate in light physical activity (e.g., walking) and simple cognitive tasks based on self-report and observational screening by the research team * Able to read and understand English (if applicable for study materials) * Able to provide informed consent * Has access to and is able to use a smartphone or mobile device to complete daily app-based activities Exclusion Criteria: * Age younger than 18 years or older than 40 years * History of moderate or severe traumatic brain injury * Concussion or mTBI occurring less than 3 months or more than 12 months prior to enrollment * Self-reported active medical disease or history of neurological or psychiatric conditions unrelated to concussion * Self-reported other medical conditions that would limit safe participation in light physical activity (e.g., walking or balance tasks) * Currently on prescribed medications that may significantly affect cognitive function, balance, neurological function, or safe participation in light physical activity * Inability to use a smartphone or mobile device required for study participation * Inability to read or understand English (as study materials and the mobile application are currently available only in English)
| Facility | City | Country | Status |
|---|---|---|---|
| University of Nevada, Las Vegas | Las Vegas, Nevada | United States |