RECRUITING

Post-Concussion Musculoskeletal Injury Risks

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Musculoskeletal injuries (MSKI) and traumatic brain injury (TBI) are the signature injuries of the ongoing military conflicts. MSKI affect 800,000 Service Members annually and TBI have impacted more than 350,000 in the past 19 years and account for 22% of all combat casualties. Concussion, a mild form of TBI, increases MSKI risk in physically active individuals, including Service Members. The overall goal of the study is to identify the neuromuscular control mechanisms that increase MSKI risk following concussion. It is hypothesized that concussed individuals will display abnormal neuromuscular function that increases MSKI risk, as compared to non-concussed controls. The study will employ a multi-center, prospective, case-matched control observational study to identify the differences in neuromuscular function following concussion that may contribute to increased MSKI risk. Once the neuromuscular control mechanisms that increase MSKI risk following concussion are identified, targeted risk mitigation strategies can be developed to reduce MSKI risk.

Official Title

Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk

Quick Facts

Study Start:2022-10-20
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05122728

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-40 years old.
  2. * Self-reported asymptomatic post-concussion following enrollment into the study and monitoring of symptoms by research personnel via daily self-reported symptom questionnaires.
  3. * Recruited within 5 days following being diagnosed with a concussion, and at least 72 hours prior to self-reporting as asymptomatic.
  4. * Access to a functional email address and the internet for completion of patient reported outcomes (PROs) and musculoskeletal injury measures.
  5. * 18-40 years old.
  6. * Active duty Service members and physically active civilians.
  7. * No self-report history of concussion within the previous 5 years.
  8. * No lingering post-concussion signs/symptoms.
  9. * Same gender as the matched concussed participant.
  10. * Within ±5% of the matched concussed participant's height, weight, and body mass index.
  11. * Within ±2 years of age of the matched concussed participant.
  12. * Participant in the same physical activities (work, recreational sports, average type \[no impact, low-impact, high-impact\] and duration of physical activity)
  1. * Post-Concussion Cohort AND Healthy Non-Concussed Cohort
  2. * Unable to read or comprehend the English language.
  3. * Admitted to the hospital following concussion.
  4. * Sustained a concussion not related to physical activity participation (e.g., blast-related injury, fall from a ladder, motor vehicle accident).
  5. * Loss of consciousness longer than 30 minutes.
  6. * Alteration in consciousness longer than 24 hours.
  7. * Post-traumatic amnesia lasting longer than 1 day.
  8. * Glasgow Coma Scale below 13.
  9. * Abnormal brain imaging findings.
  10. * Sustained a concussion that took longer than 21 days for the individual to report as asymptomatic.
  11. * A MSKI within the last 6 months that resulted in altered or missed physical activity for 3 or more consecutive days.
  12. * History of MSKI surgery.
  13. * 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).
  14. * 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.
  15. * Present with any implanted pacemaker, electronic device, or plastic/cement material

Contacts and Locations

Study Contact

Bradford D Hendershot, PhD
CONTACT
301-400-3477
bradford.d.hendershot2.civ@health.mil
Joseph G Wasser, PhD
CONTACT
301-400-2095
joseph.g.wasser.ctr@health.mil

Principal Investigator

Bradford D Hendershot, PhD
PRINCIPAL_INVESTIGATOR
Walter Reed National Military Medical Center
Robert C Lynall, PhD
STUDY_DIRECTOR
University of Georgia
Timothy C Mauntel, PhD
STUDY_DIRECTOR
Womack Army Medical Center

Study Locations (Sites)

University of Georgia
Athens, Georgia, 30602
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
United States
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
United States

Collaborators and Investigators

Sponsor: Walter Reed National Military Medical Center

  • Bradford D Hendershot, PhD, PRINCIPAL_INVESTIGATOR, Walter Reed National Military Medical Center
  • Robert C Lynall, PhD, STUDY_DIRECTOR, University of Georgia
  • Timothy C Mauntel, PhD, STUDY_DIRECTOR, Womack Army Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-20
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2022-10-20
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • musculoskeletal injury
  • biomechanics
  • movement assessment
  • neuromuscular control
  • traumatic brain injury
  • TBI
  • concussion

Additional Relevant MeSH Terms

  • Musculoskeletal Injury