Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC
- 电话号码：702-895-3492
- 邮箱：hyunhwa.lee@unlv.edu
学习地点
-
-
Nevada
-
Las Vegas、Nevada、美国、89154-3018
- University of Nevada, Las Vegas
-
接触：
- Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC
- 电话号码：702-895-3492
- 邮箱：hyunhwa.lee@unlv.edu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility and Acceptability of BraW-Day™ Intervention
大体时间：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).
|
Day 15
|
|
Change in Cognitive Function
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Depression Symptoms
大体时间：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
|
|
Change in Anxiety Symptoms
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
|
Change in Positive Affect and Well-Being
大体时间：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
|
|
Change in Stigma
大体时间：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
|
|
Change in Sensorimotor Function - Balance and Walking
大体时间：Day 0 & Day 15
|
mHealth Walking Balance (mHealth-WB) mobile application assessment of walking features and dynamic balance during gait.
|
Day 0 & Day 15
|
|
Change in Sensorimotor Function - Eye Tracking
大体时间：Day 0 & Day 15
|
EyeLink 1000 Plus System (SR Research) rapid eye movement and oculomotor function assessment.
|
Day 0 & Day 15
|
|
Change in Heart Rate Variability
大体时间：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
|
|
Change in Salivary Exosomal microRNA
大体时间：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.
|
Day 0 & Day 15
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- UNLV-2025-452
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.