Understanding musculoskeletal injury risks after concussion
Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk
This study is trying to find out how a concussion affects muscle control and increases the risk of injuries in active people, including service members, to help create better ways to keep them safe while they recover.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 148 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Walter Reed National Military Medical Center Federal |
| Locations | 3 sites (Athens, Georgia and 2 other locations) |
| Trial ID | NCT05122728 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the neuromuscular control mechanisms that increase the risk of musculoskeletal injuries (MSKI) following a concussion. It will compare concussed individuals to non-concussed controls to assess differences in neuromuscular function. The study will involve a multi-center, prospective, case-matched control design, focusing on service members and physically active civilians. By understanding these mechanisms, the study seeks to inform targeted interventions to reduce MSKI risk in individuals recovering from concussion.
Who should consider this trial
Good fit: Ideal candidates include active duty service members and physically active civilians aged 18-40 who have recently experienced a concussion or have no history of concussion in the past five years.
Not a fit: Patients who are older than 40 or have a history of concussion within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for musculoskeletal injuries in individuals recovering from concussions.
How similar studies have performed: Other studies have indicated a correlation between concussions and increased risk of musculoskeletal injuries, but this specific approach to identifying neuromuscular mechanisms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Concussed Cohort * 18-40 years old. * Self-reported asymptomatic post-concussion following enrollment into the study and monitoring of symptoms by research personnel via daily self-reported symptom questionnaires. * Recruited within 5 days following being diagnosed with a concussion, and at least 72 hours prior to self-reporting as asymptomatic. * Access to a functional email address and the internet for completion of patient reported outcomes (PROs) and musculoskeletal injury measures. Non-Concussed Cohort * 18-40 years old. * Active duty Service members and physically active civilians. * No self-report history of concussion within the previous 5 years. * No lingering post-concussion signs/symptoms. * Same gender as the matched concussed participant. * Within ±5% of the matched concussed participant's height, weight, and body mass index. * Within ±2 years of age of the matched concussed participant. * Participant in the same physical activities (work, recreational sports, average type \[no impact, low-impact, high-impact\] and duration of physical activity) Exclusion Criteria: * Post-Concussion Cohort AND Healthy Non-Concussed Cohort * Unable to read or comprehend the English language. * Admitted to the hospital following concussion. * Sustained a concussion not related to physical activity participation (e.g., blast-related injury, fall from a ladder, motor vehicle accident). * Loss of consciousness longer than 30 minutes. * Alteration in consciousness longer than 24 hours. * Post-traumatic amnesia lasting longer than 1 day. * Glasgow Coma Scale below 13. * Abnormal brain imaging findings. * Sustained a concussion that took longer than 21 days for the individual to report as asymptomatic. * A MSKI within the last 6 months that resulted in altered or missed physical activity for 3 or more consecutive days. * History of MSKI surgery. * Pregnant females (will be eligible for participation in the study once medically cleared to RTD/A by a qualified and licensed healthcare provider following the end of the pregnancy). * Participants will be excluded if they present any known contraindications for electrical stimulation. These contraindications include conditions such as: active deep vein thrombosis/thrombophlebitis, any acute injury with concurrent inflammation, hemorrhagic conditions, impaired circulation, impaired local sensations, presence of infection (osteomyelitis, tuberculosis), malignancy, recently radiated tissue, skin disease/damage and/or at-risk skin. * Present with any implanted pacemaker, electronic device, or plastic/cement material
Where this trial is running
Athens, Georgia and 2 other locations
- University of Georgia — Athens, Georgia, United States (Recruiting)
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
- Womack Army Medical Center — Fort Bragg, North Carolina, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Bradford D Hendershot, PhD — Walter Reed National Military Medical Center
- Study coordinator: Bradford D Hendershot, PhD
- Email: bradford.d.hendershot2.civ@health.mil
- Phone: 301-400-3477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.