Brain Concussion
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVirtual Neuromuscular/Dual-Task Training
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.
Sponsors
University of Colorado, Denver
Binghamton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study PI, Co-Is, and the biostatistician will not know group assignments until after the primary analyses are complete.
Intervention model description
Participants will enroll and undergo initial testing within three weeks of mTBI, be randomized to an 8-week vNDTT or standard-of-care intervention, return for post-intervention testing, and be monitored for subsequent MSK injuries in the three months after mTBI
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 18-40 years of age at the time of enrollment * Mild TBI or concussion diagnosis by a physician * Confirmed MTBI diagnosis via VA/DOD guidelines at time of enrollment * Participation in regular physical activity prior to injury (confirmed via the Global Physical Activity Questionnaire \[GPAQ\]) (Cleland et al., 2014; Keating et al., 2019) * Access to a smartphone for app download
Exclusion criteria
* Moderate or severe TBI * Pre-injury neurological disorder * Abnormal brain imaging findings (if performed as a part of routine care) * Previous TBI (mild/moderate/severe) \<12 months prior to enrollment other than the current injury for which they are being seen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Injury rate | 3 months after mTBI | Acute musculoskeletal injury rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention adherence | Upon enrollment and for the subsequent 8 weeks | Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions |
| Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference | 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 |
| Sleep quality | 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 |
| Dizziness | 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 |
| Anxiety | 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 |
| Single/dual-task standing and gait | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid R Howell, PhD
University of Colorado School of Medicine
Outcome results
None listed