Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery

Официальное название

Boosting Brain and Balance: A Mobile Dual-Task Intervention for Athletes With Concussion and Mild Traumatic Brain Injury (mTBI)

Обзор

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.

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.

Вмешательства

• Поведенческое 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 progressiv

Первичные конечные точки

• Feasibility and Acceptability of BraW-Day™ Intervention [Срок оценки: Day 15]
• Change in Cognitive Function [Срок оценки: Day 0 & Day 15]

Вторичные конечные точки (12)

• Change in Depression Symptoms [Срок оценки: Day 0 & Day 15]
• Change in Anxiety Symptoms [Срок оценки: Day 0 & Day 15]
• Change in Fatigue [Срок оценки: Day 0 & Day 15]
• Change in Sleep Disturbance [Срок оценки: Day 0 & Day 15]
• Change in Emotional and Behavioral Dyscontrol [Срок оценки: Day 0 & Day 15]
• Change in Ability to Participate in Social Roles and Activities [Срок оценки: Day 0 & Day 15]
• Change in Positive Affect and Well-Being [Срок оценки: Day 0 & Day 15]
• Change in Stigma [Срок оценки: Day 0 & Day 15]
• Change in Sensorimotor Function - Balance and Walking [Срок оценки: Day 0 & Day 15]
• Change in Sensorimotor Function - Eye Tracking [Срок оценки: Day 0 & Day 15]
• Change in Heart Rate Variability [Срок оценки: Day 0 & Day 15]
• Change in Salivary Exosomal microRNA [Срок оценки: Day 0 & Day 15]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Nevada, Las Vegas — Las Vegas

Публикации

• 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. PMID 19254600
• 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 PMID 31036562
• 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. PMID 28399158
• 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. PMID 8551320
• 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. PMID 21749974
• 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. PMID 28148495
• 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. PMID 18025964
• 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/W PMID 22573626

Идентификаторы

NCT: NCT07599475 · UNLV-2025-452

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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