Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery

NCT07599475 | Not Yet Recruiting

• 1 other identifier: UNLV-2025-452
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Traumatic Brain Injury (mTBI); Sports-related Concussion; Heart Rate Variability (HRV); Walking; Oculomotor; Saliva; Exosomal microRNA; Cognitive Function

Keywords

dual-task; mild traumatic brain injury (mTBI); sports-related concussion; BraW-Day

Outcome Measures

Primary Outcomes (2)

• Feasibility and Acceptability of BraW-Day™ Intervention

  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

  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

Secondary Outcomes (12)

• Change in Depression Symptoms

  Day 0 & Day 15

• Change in Anxiety Symptoms

  Day 0 & Day 15

• Change in Fatigue

  Day 0 & Day 15

• Change in Sleep Disturbance

  Day 0 & Day 15

• Change in Emotional and Behavioral Dyscontrol

  Day 0 & Day 15

Study Arms (1)

14-Day BraW-Day™ Intervention

EXPERIMENTAL

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).

Behavioral: Home-Based Mobile Dual-Task Intervention (BraW-Day™)

Interventions

Home-Based Mobile Dual-Task Intervention (BraW-Day™) BEHAVIORAL

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.

14-Day BraW-Day™ Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hyunhwa Lee: lead
• University of Nevada, Las Vegas: collaborator

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154-3018, United States

Location

Related Publications (9)

• 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 BACKGROUND

• 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.

  PMID: 31036562 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 22573626 BACKGROUND

• 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.

  PMID: 34663623 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

Hyunhwa Lee, PhD, MSN, APRN, PMHNP-BC

CONTACT

702-895-3492; hyunhwa.lee@unlv.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty, School of Nursing

Model Details: All eligible participants will receive the 14-day BraW-Day™ mobile dual-task intervention. This is a single-arm, pre-post design with assessments at baseline and immediately following the 14-day intervention period. There is no control or comparison group.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (1)