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Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery

14 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC
  • Numer telefonu: 702-895-3492
  • E-mail: hyunhwa.lee@unlv.edu

Lokalizacje studiów

  • Stany Zjednoczone
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89154-3018
        • University of Nevada, Las Vegas
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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).
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Feasibility and Acceptability of BraW-Day™ Intervention
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Depression Symptoms
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hyunhwa Lee

Współpracownicy

University of Nevada, Las Vegas

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 maja 2026

Zakończenie podstawowe (Szacowany)

30 kwietnia 2027

Ukończenie studiów (Szacowany)

30 kwietnia 2027

Daty rejestracji na studia

Pierwszy przesłany

14 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 maja 2026

Pierwszy wysłany (Rzeczywisty)

20 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • UNLV-2025-452

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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).

Ramy czasowe udostępniania 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.

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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