University of Colorado Denver
Aurora, Colorado, 80045, United States
NCT Number: NCT05594225
The goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered virtual Neuromuscular/Dual-Task (vNDT) intervention among healthy U.S. military service members and physically active young adults with a recent concussion.
This study is active but is not currently recruiting participants.
Notify Me18 year–40 year
All sexes
Interventional
Phase 1
Aurora, Colorado, 80045, United States
Aim 1. Determine the baseline neuromuscular/dual-task performance characteristics among a sample of active-duty military service members compared to physically active young adult civilians.
The investigators hypothesize that active-duty military service members will have similar baseline gait and dual-task abilities as civilians, demonstrating translation potential between populations.
The investigators also hypothesize that baseline gait and dual-task abilities will be influenced by history of prior mTBI injuries among military Service Members.
Aim 2. Examine the efficacy of a smartphone-based vNDTT intervention to reduce musculoskeletal injury and improve neuromuscular/dual-task performance after a recent mTBI.
The investigators hypothesize that those randomized to the intervention within three weeks of mTBI will have a lower risk of MSK injury in the 3-month period following mTBI, relative to standard-of-care.
The investigators also hypothesize that those randomized to the intervention within three weeks of mTBI will have better post-intervention gait and dual-task performance than those assigned to standard-of-care, despite similar baseline performance.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks.
Time frame: 3 months after mTBI
Acute musculoskeletal injury rate
Time frame: Upon enrollment and for the subsequent 8 weeks
Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Patient-Reported Outcomes Measurement Information System (PROMIS) global questionnaire
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Participants will complete the Pittsburgh Sleep Quality Inventory
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Participants will complete the Dizziness Handicap Inventory
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Participants will complete the General Anxiety Disorder - 7 scale
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Participants will perform walking trials under single and dual-task conditions
University of Colorado, Denver
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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