Recruiting

Observational Study

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT05122728

Conditions

Musculoskeletal Injury

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk Assessment

Study Details

Brief summary:

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.

Conditions

Musculoskeletal Injury

Study ID

NCT05122728

Start date

Oct 20, 2022

Status verified date

Jan, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

148 participants

Anticipated

Interventions and Outcome Measures

Arms

Concussed Cohort

Active duty Service Members and physically active civilians who have self-reported as asymptomatic post-concussion.

Non-Concussed Cohort

Gender, age, occupation, and physical activity matched active duty Service Members and physically active civilians who have not sustained a concussion.

Interventions

Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk Assessment

Participants will complete a comprehensive biomechanical and neuromuscular assessments to elucidate the underlying neuromuscular control mechanisms that may contribute to increased MSKI risk following concussion. Participants will also complete a battery of self-report psychosocial measures.

Biomechanical Dynamic Movement Assessments:

  • Jump-Landing
  • Single Leg Hop
  • Anticipated Cut
  • Gait - Single Task
  • Gait - Dual Task

Strength and Voluntary Muscle Activation Assessments:

  • Interpolated Twitch Technique
  • Muscular Ramp Contraction

Sensory assessments:

  • Proprioception - Closed Chain
  • Passive Joint Repositioning
  • Light Touch Sensation

Patient Reported Outcomes:

  • Self-Reported Musculoskeletal Injuries
  • National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
  • PROMIS Pain Interference
  • PROMIS Depression
  • PROMIS Anxiety
  • Brief Resilience Scale (BRS)
  • Tampa Scale of Kinesiophobia (TSK-11)

Primary outcome measure

  • Changes in Jump-Landing Kinematic and Kinetic Measures [ Time Frame: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing. ]
  • Changes in Single Leg Hop Kinematic and Kinetic Measures [ Time Frame: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing. ]
  • Changes in Anticipated Cut Kinematic and Kinetic Measures [ Time Frame: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing. ]
  • Changes in Single-Task Gait Kinematic and Kinetic Measures [ Time Frame: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing. ]
  • Changes in Dual-Task Gait Kinematic and Kinetic Measures [ Time Frame: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing. ]
  • Changes in Interpolated Twitch Technique Measurements [ Time Frame: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing. ]
  • Changes in Muscular Ramp Contraction Measurements [ Time Frame: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing. ]
  • Changes in Closed-Chain Proprioception [ Time Frame: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing. ]
  • Changes in Passive Joint Repositioning [ Time Frame: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing, ]
  • Changes in Light Touch Sensation [ Time Frame: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing. ]
  • Changes in Self-Reported Musculoskeletal Injuries [ Time Frame: Monthly, through study completion (an average of 1 year) ]
  • Changes in NIH-PROMIS Physical Function [ Time Frame: Monthly, through study completion (an average of 1 year) ]
  • Changes in NIH-PROMIS Pain Interference [ Time Frame: Monthly, through study completion (an average of 1 year) ]
  • Changes in NIH-PROMIS Depression [ Time Frame: Monthly, through study completion (an average of 1 year) ]
  • Changes in NIH-PROMIS Anxiety [ Time Frame: Monthly, through study completion (an average of 1 year) ]
  • Changes in the Brief Resilience Scale (BRS) [ Time Frame: Monthly, through study completion (an average of 1 year) ]
  • Changes in the Tampa Scale of Kinesiophobia [ Time Frame: Monthly, through study completion (an average of 1 year) ]

Central Contacts and Locations

Central contacts

Bradford D Hendershot, PhD

301-400-3477bradford.d.hendershot2.civ@health.mil

Joseph G Wasser, PhD

301-400-2095joseph.g.wasser.ctr@health.mil

Locations

University of Georgia

Recruiting

Athens, Georgia, United States, 30602

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20814

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2026-01-27.