Mild Traumatic Brain Injury (mTBI)NCT07599475
Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery
A study testing Home-Based Mobile Dual-Task Intervention (BraW-Day™) in people with Mild Traumatic Brain Injury (mTBI) and Sports-related Concussion, run by Hyunhwa Lee at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mild Traumatic Brain Injury (mTBI), Sports-related Concussion, Heart Rate Variability (HRV)
- What is being tested?
- Home-Based Mobile Dual-Task Intervention (BraW-Day™)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154-3018
Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC, 702-895-3492, hyunhwa.lee@unlv.edu
About this study
Official title: Boosting Brain and Balance: A Mobile Dual-Task Intervention for Athletes With Concussion and Mild Traumatic Brain Injury (mTBI)
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Mild Traumatic Brain Injury (mTBI), Sports-related Concussion, Heart Rate Variability (HRV), Walking, Oculomotor, Saliva
- Being tested
- Home-Based Mobile Dual-Task Intervention (BraW-Day™)
- Keywords
- dual-task, mild traumatic brain injury (mTBI), sports-related concussion, BraW-Day
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Mobile Dual-Task Intervention (BraW-Day™)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 14-Day BraW-Day™ Intervention | Experimental | 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). Receives: Behavioral: Home-Based Mobile Dual-Task Intervention (BraW-Day™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability of BraW-Day™ Intervention
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).
Measured: Day 15
Change in Cognitive Function
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.
Measured: Day 0 & Day 15
Secondary outcomes (12)
Change in Depression Symptoms
Neuro-QOL Depression Short Form assessing depressive symptoms. T-scores (mean 50, SD 10); higher scores indicate worse depressive symptoms.
Measured: Day 0 & Day 15
Change in Anxiety Symptoms
Neuro-QOL Anxiety Short Form assessing anxiety symptoms. T-scores (mean 50, SD 10); higher scores indicate worse anxiety.
Measured: Day 0 & Day 15
Change in Fatigue
Neuro-QOL Fatigue Short Form assessing fatigue severity and impact. T-scores (mean 50, SD 10); higher scores indicate worse fatigue.
Measured: Day 0 & Day 15
Change in Sleep Disturbance
Neuro-QOL Sleep Disturbance Short Form assessing sleep quality and disturbance. T-scores (mean 50, SD 10); higher scores indicate worse sleep disturbance.
Measured: Day 0 & Day 15
Change in Emotional and Behavioral Dyscontrol
Neuro-QOL Emotional and Behavioral Dyscontrol Short Form assessing emotional regulation and impulsivity. T-scores (mean 50, SD 10); higher scores indicate worse dyscontrol.
Measured: Day 0 & Day 15
Change in Ability to Participate in Social Roles and Activities
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.
Measured: Day 0 & Day 15
Change in Positive Affect and Well-Being
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.
Measured: Day 0 & Day 15
Change in Stigma
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.
Measured: Day 0 & Day 15
Change in Sensorimotor Function - Balance and Walking
mHealth Walking Balance (mHealth-WB) mobile application assessment of walking features and dynamic balance during gait.
Measured: Day 0 & Day 15
Change in Sensorimotor Function - Eye Tracking
EyeLink 1000 Plus System (SR Research) rapid eye movement and oculomotor function assessment.
Measured: Day 0 & Day 15
Change in Heart Rate Variability
8-minute seated rest recording measuring cardiac autonomic nervous system function. Higher HRV indicates better parasympathetic tone and cardiovascular function.
Measured: Day 0 & Day 15
Change in Salivary Exosomal microRNA
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.
Measured: Day 0 & Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start15 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain Injury (mTBI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible participants will receive the 14-day BraW-Day™ mobile dual-task intervention. This is a single-arm, pre-post design with assessments at baseline and immediately following the 14-day intervention period. There is no control or comparison group.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyunhwa Lee
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nevada, Las Vegas
- Responsible party
- Sponsor-investigator, Hyunhwa Lee, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599475
- Sponsor's protocol ID
- UNLV-2025-452
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying results published from this study will be shared, including: baseline demographic and clinical characteristics; cognitive assessments (Neuro-QOL Cognitive Function); psychosocial measures (depression, anxiety, fatigue, sleep disturbance, emotional dyscontrol, stigma, social participation, well-being); sensorimotor outcomes (gait analysis, balance, eye-tracking); heart rate variability; intervention adherence data; and interview feedback on acceptability and feasibility. Data will be de-identified and shared via secure institutional database or upon researcher request under a data use agreement. Requests should be directed to the Principal Investigator (hyunhwa.lee@unlv.edu). Data will be available beginning six months after publication of primary outcomes through study data retention period (6 years).
Publications
Silsupadol P, Shumway-Cook A, Lugade V, van Donkelaar P, Chou LS, Mayr U, Woollacott MH. Effects of single-task versus dual-task training on balance performance in older adults: a double-blind, randomized controlled trial. Arch Phys Med Rehabil. 2009 Mar;90(3):381-7. doi: 10.1016/j.apmr.2008.09.559.
PubMed 19254600McCrea M, Broglio S, McAllister T, Zhou W, Zhao S, Katz B, Kudela M, Harezlak J, Nelson L, Meier T, Marshall SW, Guskiewicz KM; CARE Consortium Investigators. Return to play and risk of repeat concussion in collegiate football players: comparative analysis from the NCAA Concussion Study (1999-2001) and CARE Consortium (2014-2017). Br J Sports Med. 2020 Jan;54(2):102-109. doi: 10.1136/bjsports-2019-100579. Epub 2019 Apr 29.
PubMed 31036562McInnes K, Friesen CL, MacKenzie DE, Westwood DA, Boe SG. Mild Traumatic Brain Injury (mTBI) and chronic cognitive impairment: A scoping review. PLoS One. 2017 Apr 11;12(4):e0174847. doi: 10.1371/journal.pone.0174847. eCollection 2017.
PubMed 28399158King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.
PubMed 8551320Hamilton CM, Strader LC, Pratt JG, Maiese D, Hendershot T, Kwok RK, Hammond JA, Huggins W, Jackman D, Pan H, Nettles DS, Beaty TH, Farrer LA, Kraft P, Marazita ML, Ordovas JM, Pato CN, Spitz MR, Wagener D, Williams M, Junkins HA, Harlan WR, Ramos EM, Haines J. The PhenX Toolkit: get the most from your measures. Am J Epidemiol. 2011 Aug 1;174(3):253-60. doi: 10.1093/aje/kwr193. Epub 2011 Jul 11.
PubMed 21749974Dobson JL, Yarbrough MB, Perez J, Evans K, Buckley T. Sport-related concussion induces transient cardiovascular autonomic dysfunction. Am J Physiol Regul Integr Comp Physiol. 2017 Apr 1;312(4):R575-R584. doi: 10.1152/ajpregu.00499.2016. Epub 2017 Feb 1.
PubMed 28148495Corrigan JD, Bogner J. Initial reliability and validity of the Ohio State University TBI Identification Method. J Head Trauma Rehabil. 2007 Nov-Dec;22(6):318-29. doi: 10.1097/01.HTR.0000300227.67748.77.
PubMed 18025964Cella D, Lai JS, Nowinski CJ, Victorson D, Peterman A, Miller D, Bethoux F, Heinemann A, Rubin S, Cavazos JE, Reder AT, Sufit R, Simuni T, Holmes GL, Siderowf A, Wojna V, Bode R, McKinney N, Podrabsky T, Wortman K, Choi S, Gershon R, Rothrock N, Moy C. Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology. Neurology. 2012 Jun 5;78(23):1860-7. doi: 10.1212/WNL.0b013e318258f744. Epub 2012 May 9.
PubMed 22573626Brett BL, Kerr ZY, Walton SR, Chandran A, Defreese JD, Mannix R, Echemendia RJ, Meehan WP, Guskiewicz KM, McCrea M. Longitudinal trajectory of depression symptom severity and the influence of concussion history and physical function over a 19-year period among former National Football League (NFL) players: an NFL-LONG Study. J Neurol Neurosurg Psychiatry. 2022 Mar;93(3):272-279. doi: 10.1136/jnnp-2021-326602. Epub 2021 Oct 18.
PubMed 34663623
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Brain and Balance: A Mobile Dual-Task Intervention for Athletes With Concussion and Mild Traumatic Brain Injury (mTBI)
- ClinicalTrials.gov ID
- NCT07599475
- Acronym / sponsor ID
- UNLV-2025-452
- Conditions
- Mild Traumatic Brain Injury (mTBI), Sports-related Concussion, Heart Rate Variability (HRV), Walking, Oculomotor, Saliva
- Keywords
- dual-task, mild traumatic brain injury (mTBI), sports-related concussion, BraW-Day
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hyunhwa LeeUniversity, hospital or other
- Collaborators
- University of Nevada, Las Vegas
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible participants will receive the 14-day BraW-Day™ mobile dual-task intervention. This is a single-arm, pre-post design with assessments at baseline and immediately following the 14-day intervention period. There is no control or comparison group.
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Mobile Dual-Task Intervention (BraW-Day™)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. | Behavioural | 14-Day BraW-Day™ Intervention |
Primary outcome
Feasibility and Acceptability of BraW-Day™ Intervention
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).
Change in Cognitive Function
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.
12 secondary outcomes
Change in Depression Symptoms
Time frame: Day 0 & Day 15
Change in Anxiety Symptoms
Time frame: Day 0 & Day 15
Change in Fatigue
Time frame: Day 0 & Day 15
Change in Sleep Disturbance
Time frame: Day 0 & Day 15
Change in Emotional and Behavioral Dyscontrol
Time frame: Day 0 & Day 15
Change in Ability to Participate in Social Roles and Activities
Time frame: Day 0 & Day 15
Change in Positive Affect and Well-Being
Time frame: Day 0 & Day 15
Change in Stigma
Time frame: Day 0 & Day 15
Change in Sensorimotor Function - Balance and Walking
Time frame: Day 0 & Day 15
Change in Sensorimotor Function - Eye Tracking
Time frame: Day 0 & Day 15
Change in Heart Rate Variability
Time frame: Day 0 & Day 15
Change in Salivary Exosomal microRNA
Time frame: Day 0 & Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 19254600Silsupadol P, Shumway-Cook A, Lugade V, van Donkelaar P, Chou LS, Mayr U, Woollacott MH. Effects of single-task versus dual-task training on balance performance in older adults: a double-blind, randomized controlled trial. Arch Phys Med Rehabil. 2009 Mar;90(3):381-7. doi: 10.1016/j.apmr.2008.09.559.
- Background: PubMed 31036562McCrea M, Broglio S, McAllister T, Zhou W, Zhao S, Katz B, Kudela M, Harezlak J, Nelson L, Meier T, Marshall SW, Guskiewicz KM; CARE Consortium Investigators. Return to play and risk of repeat concussion in collegiate football players: comparative analysis from the NCAA Concussion Study (1999-2001) and CARE Consortium (2014-2017). Br J Sports Med. 2020 Jan;54(2):102-109. doi: 10.1136/bjsports-2019-100579. Epub 2019 Apr 29.
- Background: PubMed 28399158McInnes K, Friesen CL, MacKenzie DE, Westwood DA, Boe SG. Mild Traumatic Brain Injury (mTBI) and chronic cognitive impairment: A scoping review. PLoS One. 2017 Apr 11;12(4):e0174847. doi: 10.1371/journal.pone.0174847. eCollection 2017.
- Background: PubMed 8551320King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.
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- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying results published from this study will be shared, including: baseline demographic and clinical characteristics; cognitive assessments (Neuro-QOL Cognitive Function); psychosocial measures (depression, anxiety, fatigue, sleep disturbance, emotional dyscontrol, stigma, social participation, well-being); sensorimotor outcomes (gait analysis, balance, eye-tracking); heart rate variability; intervention adherence data; and interview feedback on acceptability and feasibility. Data will be de-identified and shared via secure institutional database or upon researcher request under a data use agreement. Requests should be directed to the Principal Investigator (hyunhwa.lee@unlv.edu). Data will be available beginning six months after publication of primary outcomes through study data retention period (6 years).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Mobile Dual-Task Intervention (BraW-Day™) in people with Mild Traumatic Brain Injury (mTBI) and Sports-related Concussion, run by Hyunhwa Lee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC (702-895-3492, hyunhwa.lee@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability of BraW-Day™ Intervention (time frame: Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07599475, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.