Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery
2026年5月14日 更新者：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.
調査の概要
状態
状態
まだ募集していません
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
介入
入学 (推定)
入学
20
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC
- 電話番号：702-895-3492
- メール：hyunhwa.lee@unlv.edu
研究場所
-
-
Nevada
-
Las Vegas、Nevada、アメリカ、89154-3018
- University of Nevada, Las Vegas
-
コンタクト：
- Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC
- 電話番号：702-895-3492
- メール：hyunhwa.lee@unlv.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
1
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility and Acceptability of BraW-Day™ Intervention
時間枠：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
|
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Change in Cognitive Function
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Depression Symptoms
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
協力者
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年5月15日
一次修了 (推定)
一次修了
2027年4月30日
研究の完了 (推定)
研究の完了
2027年4月30日
試験登録日
最初に提出
最初に提出
2026年5月14日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年5月14日
最初の投稿 (実際)
最初の投稿
2026年5月20日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年5月20日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年5月14日
最終確認日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- UNLV-2025-452
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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).
IPD 共有時間枠
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.
IPD 共有アクセス基準
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。