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| Name | Class |
|---|---|
| Binghamton University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Neuromuscular/Dual-Task Training | Experimental | 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. |
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| Standard-of-care | No Intervention | Participants will be provided routine instructions related to physical activity and rehabilitation exercises |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Neuromuscular/Dual-Task Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Injury rate | Acute musculoskeletal injury rate | 3 months after mTBI |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention adherence | Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions | Upon enrollment and for the subsequent 8 weeks |
| Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Howell, PhD | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
Unidentified/blinded IPD data may be made available upon reasonable request.
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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
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The study PI, Co-Is, and the biostatistician will not know group assignments until after the primary analyses are complete.
Patient-Reported Outcomes Measurement Information System (PROMIS) global questionnaire |
| During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test |
| Sleep quality | Participants will complete the Pittsburgh Sleep Quality Inventory | During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test |
| Dizziness | Participants will complete the Dizziness Handicap Inventory | During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test |
| Anxiety | Participants will complete the General Anxiety Disorder - 7 scale | During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test |
| Single/dual-task standing and gait | Participants will perform walking trials under single and dual-task conditions | During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |