Understanding musculoskeletal injury risks after concussion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.