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Behavioural Intervention

Dual-Task Exercise for Concussions

N/A
Recruiting
Research Sponsored by University of Nevada, Las Vegas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female adults aged 18-40 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days
Awards & highlights

Summary

This trial will test a 14-day exercise program on app to help young adults with mild traumatic brain injury improve cognition and movement.

Who is the study for?
This trial is for adults aged 18-40 who've had a mild traumatic brain injury (mTBI) in the past 3 months to 2 years. It's open to student athletes, Veterans, and ethnic minorities who understand the study and can do all activities. People with other serious medical conditions, psychiatric issues, substance abuse problems, learning disorders or ADHD are not eligible.
What is being tested?
The trial tests a mobile app called Uplode that guides users through a virtual dual-task walking exercise program named BraW-Day for two weeks. The goal is to see if it helps improve cognition, sensorimotor functions, and other areas affected by mTBI.
What are the potential side effects?
Since this intervention involves physical exercise and cognitive tasks using an app, potential side effects may include typical exercise-related discomforts such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 40 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability, feasibility of the BraW-Day program on Uplode app
Change in cognitive function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
Change in psychosocial function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
+3 more
Secondary study objectives
Change in salivary exosomal microRNA from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The intervention group will be asked to visit the UNLV study site three times to evaluate baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).
Group II: Wait-list ControlActive Control1 Intervention
The wait-list control group will be will be asked to visit the UNLV study site four times to evaluate pre-baseline (T0), baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).

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Who is running the clinical trial?

University of Nevada, Las VegasLead Sponsor
70 Previous Clinical Trials
13,944 Total Patients Enrolled
~18 spots leftby Jan 2025
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