Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery
14 мая 2026 г. обновлено: Hyunhwa Lee
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.
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.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
20
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC
- Номер телефона: 702-895-3492
- Электронная почта: hyunhwa.lee@unlv.edu
Места учебы
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Nevada
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Las Vegas, Nevada, Соединенные Штаты, 89154-3018
- University of Nevada, Las Vegas
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Контакт:
- Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC
- Номер телефона: 702-895-3492
- Электронная почта: hyunhwa.lee@unlv.edu
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-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
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)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 14-Day BraW-Day™ Intervention
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).
|
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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Feasibility and Acceptability of BraW-Day™ Intervention
Временное ограничение: Day 15
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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).
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Day 15
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Change in Cognitive Function
Временное ограничение: 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.
|
Day 0 & Day 15
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Depression Symptoms
Временное ограничение: Day 0 & Day 15
|
Neuro-QOL Depression Short Form assessing depressive symptoms.
T-scores (mean 50, SD 10); higher scores indicate worse depressive symptoms.
|
Day 0 & Day 15
|
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Change in Anxiety Symptoms
Временное ограничение: Day 0 & Day 15
|
Neuro-QOL Anxiety Short Form assessing anxiety symptoms.
T-scores (mean 50, SD 10); higher scores indicate worse anxiety.
|
Day 0 & Day 15
|
|
Change in Fatigue
Временное ограничение: 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.
|
Day 0 & Day 15
|
|
Change in Sleep Disturbance
Временное ограничение: 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.
|
Day 0 & Day 15
|
|
Change in Emotional and Behavioral Dyscontrol
Временное ограничение: 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.
|
Day 0 & Day 15
|
|
Change in Ability to Participate in Social Roles and Activities
Временное ограничение: 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.
|
Day 0 & Day 15
|
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Change in Positive Affect and Well-Being
Временное ограничение: 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.
|
Day 0 & Day 15
|
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Change in Stigma
Временное ограничение: 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.
|
Day 0 & Day 15
|
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Change in Sensorimotor Function - Balance and Walking
Временное ограничение: Day 0 & Day 15
|
mHealth Walking Balance (mHealth-WB) mobile application assessment of walking features and dynamic balance during gait.
|
Day 0 & Day 15
|
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Change in Sensorimotor Function - Eye Tracking
Временное ограничение: Day 0 & Day 15
|
EyeLink 1000 Plus System (SR Research) rapid eye movement and oculomotor function assessment.
|
Day 0 & Day 15
|
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Change in Heart Rate Variability
Временное ограничение: Day 0 & Day 15
|
8-minute seated rest recording measuring cardiac autonomic nervous system function.
Higher HRV indicates better parasympathetic tone and cardiovascular function.
|
Day 0 & Day 15
|
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Change in Salivary Exosomal microRNA
Временное ограничение: 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.
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Day 0 & Day 15
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- King 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.
- Cella 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.
- Corrigan 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.
- Hamilton 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.
- 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.
- McCrea 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.
- McInnes 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.
- Dobson 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.
- Brett 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
15 мая 2026 г.
Первичное завершение (Оцененный)
30 апреля 2027 г.
Завершение исследования (Оцененный)
30 апреля 2027 г.
Даты регистрации исследования
Первый отправленный
14 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
14 мая 2026 г.
Первый опубликованный (Действительный)
20 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
20 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
14 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- UNLV-2025-452
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
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).
Сроки обмена IPD
Individual participant data and supporting information will be available beginning 6 months after publication of primary results and will remain available for 6 years from the date of study completion, consistent with institutional data retention requirements.
Критерии совместного доступа к IPD
De-identified data will be available to qualified researchers upon written request to the Principal Investigator.
A Data Use Agreement will be required specifying that data will be used only for approved research purposes, securely stored, and not re-identified or shared with unauthorized parties.
Data will be provided via secure transfer within 15 business days of request approval.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .