Post-Concussion Musculoskeletal Injury Risks

NCT05122728 | Recruiting

• 1 other identifier: WRNMMC-2021-0362
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (17)

• Changes in Jump-Landing Kinematic and Kinetic Measures

  The participant will stand on a 30cm tall box, set at a distance that is equal to 50% of the participant's height behind a set of force platforms. Once the participant receives a visual stimulus, he/she will jump so that both feet leave the box at the same time. Upon landing the participant will immediately jump vertically for maximal height. Participants will complete 5 jump-landings. Whole body biomechanics will be collected and kinematic and kinetic measures will be identified at initial ground contact ("initial contact"), the peak angle ("max") during the "landing phase" of the initial landings of the jump-landing, and the difference between these angles ("displacement").

  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

  The participant will stand on a 30cm tall box, set at a distance that is equal to 50% of the participant's height behind a set of force platforms. Once the participant receives a visual stimulus, he/she will jump so that both feet leave the box at the same time. The participant will jump off the box and land on a single leg with hands on hips. Participants will be instructed to come to a stable position as quickly as possible upon landing. Participants will perform 5 single leg hop trials on each leg (10 total trials). Whole body biomechanics will be collected and kinematic and kinetic measures will be identified at initial ground contact ("initial contact"), the peak angle ("max") during the "landing phase" of the initial landings of the single leg-hop, and the difference between these angles ("displacement").

  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

  The participant will stand on a 30cm tall box, set at a distance that is equal to 50% of the participant's height behind a set of force platforms. Once the participant receives a visual stimulus, he/she will jump so that both feet leave the box at the same time. The participant will jump off the box and land on a single leg. Immediately upon landing, the participant will cut at a 45° angle (marked with tape on floor) in the direction provided by the study team prior to the trial (cut towards dominant = land on non-dominant foot; cut towards non-dominant = land on dominant foot). Participants will complete 5 trials cutting in each direction (10 total trials). Whole body biomechanics will be collected and kinematic and kinetic measures will be identified at initial ground contact ("initial contact"), the peak angle ("max") during the "landing phase" of the initial landings of the anticipated cutting tasks, and the difference between these angles ("displacement").

  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

  Participants will complete over-ground gait trials at self-selected walking speed. Participants will start approximately 3m in front of the force platforms so that he/she is at a steady walking speed by the time the participant's foot makes contact with a force platform. No verbal instructions will be provided to indicate that clean foot strikes are required, and participants will be instructed to look straight ahead while walking (i.e., minimizing "targeting"). Participants will complete 5 gait trials so that each foot makes contact with the force platform (10 total trials) for both tasks. Gait velocity, center of mass displacement, and center of mass velocity will be collected from these tasks.

  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

  Participants will complete over-ground gait trials as well as gait tasks under a dual-task condition at self-selected walking speed. Participants will start approximately 3m in front of the force platforms so that he/she is at a steady walking speed by the time the participant's foot makes contact with a force platform. No verbal instructions will be provided to indicate that clean foot strikes are required, and participants will be instructed to look straight ahead while walking (i.e., minimizing "targeting"). During dual-task conditions participants will complete Serial Sevens, Serial Nines, etc. Participants will start counting at a randomly generated number between 80 and 120 and will count backwards by the designated denomination. Participants will complete 5 gait trials so that each foot makes contact with the force platform (10 total trials) for both tasks. Gait velocity, center of mass displacement, and center of mass velocity will be collected from these tasks.

  Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.

• Changes in Interpolated Twitch Technique Measurements

  Participants will be seated in the dynamometer so that the axis of rotation of the participants' dominant knee coincides with the servomotor. Participants will be secured to the chair using seat belts along the chest, waist, and ankle. Adhesive stimulating electrodes will be placed on the skin overlying the distal vastus medialis muscle and proximal vastus lateralis muscle of the thigh on the dominant leg and will be controlled by electrical stimulators. Participants will perform a maximal voluntary isometric contraction (MVIC). During the MVIC, the muscle group will be stimulated with a paired-pulse stimulation, and the increase in torque over the MVIC level (i.e., interpolated twitch torque \[ITT\]) will be recorded. Following the MVIC, the paired-pulsed stimulation will be administered again (twice) to the relaxed muscle to determine peak electrically-evoked twitch torque (EET).

  Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.

• Changes in Muscular Ramp Contraction Measurements

  Participants will be seated in the dynamometer so that the axis of rotation of the participants' dominant knee coincides with the servomotor. Participants will be secured to the chair using seat belts along the chest, waist, and ankle. Adhesive stimulating electrodes will be placed on the skin overlying the distal vastus medialis muscle and proximal vastus lateralis muscle of the thigh on the dominant leg, and will be controlled by electrical stimulators. Participants will perform three maximal voluntary isometric contractions (MVIC). The maximal voluntary muscle torque will be determined from this initial test and then used to create a ramping protocol in which the participant will ramp from 20 -100% maximal voluntary contraction over a 2.5 second period.

  Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.

• Changes in Closed-Chain Proprioception

  The participant will stand with feet shoulder-width apart, feet (toes) pointed anteriorly, heels on the floor, and hands clasped in front of the participants chest. Participants will be asked to squat in a deep, slow, and controlled manner, to what they believe is 60-degrees of knee flexion and to hold that position for 5 seconds. Participants will then return to a full, upright position, march in place 10 times (5 each leg), and regain the original starting position. Participants will then be asked to replicate the same knee joint angle as they did in their initial trials. Participants will perform 3 trials following the initial trial (4 total trials).

  Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.

• Changes in Passive Joint Repositioning

  Participants will be assessed using the passive motion and direction threshold method on a research dynamometer that passively moves the participant's dominant leg until the minimal detectable change in joint angle is perceived. Participants will be secured to the dynamometer while blindfolded and listening to static noise through headphones to eliminate movement cues. Initial starting positions will be 10° and 125° of knee flexion while the dominant knee will be passively moved at 5°/sec in either flexion or extension directions. The participant will be instructed to hit the "stop" button on the dynamometer once he/she perceives any movement, locking the dynamometer moment arm from moving and while the joint angle is recorded. Participants will perform 2 trials for each range (9 total trials).

  Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing,

• Changes in Light Touch Sensation

  Participants will be assessed using Semmes-Weinstein Monofilaments via a "4-2-1" stepping protocol using 20 force-calibrated nylon threads to assess sensory detection thresholds. Participants will lay prone on a treatment table, with their shoe and sock off of their dominant foot, listening to static noise through headphones, while the threads are applied until a "C" shaped bend occurs and is held for 1 second. The threads will be applied using a standard "4-2-1" stepping protocol for one trial. The light touch sensation main outcome measure is the diameter of the thread on the final application.

  Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.

• Changes in Self-Reported Musculoskeletal Injuries

  Participants will report all of their previous MSKI sustained within 1- year prior to enrollment into the study and any "severe" MSKI they have sustained that resulted in 3 or more consecutive weeks of missed physical activity. Participants will also self-report if they sustain any new MSKIs during the study follow-up period. MSKIs will be operationally defined as: 1) a MSKI that required the participant to seek medical attention from a healthcare provider; or 2) a MSKI that required the participant to not participate in normal physical activity for 3 or more consecutive days. The following information will be self-reported for each injury: 1) date of injury; 2) activity at the time of injury; 3) mechanism of injury (overuse, traumatic); 4) if the injury is recurrent (i.e., previously experienced); and 5) if the MSKI resulted in less than or more than 1 week of missed or altered physical activity.

  Monthly, through study completion (an average of 1 year)

• Changes in NIH-PROMIS Physical Function

  Physical Function measures an individual's self-reported capabilities rather than his/her actual performance of physical activities. The assessment includes functioning of an individual's upper and lower extremities and neck and spine across a variety of activities.

  Monthly, through study completion (an average of 1 year)

• Changes in NIH-PROMIS Pain Interference

  Pain Interference measures an individual's self-reported consequences of pain on one's life over the past 7 days. This includes the extent to which pain hinders social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items that assess sleep and enjoyment of life.

  Monthly, through study completion (an average of 1 year)

• Changes in NIH-PROMIS Depression

  Depression measures an individual's self-reported negative mood, views of self, social cognition, and decreased positive affect and engagement over the past 7 days.

  Monthly, through study completion (an average of 1 year)

• Changes in NIH-PROMIS Anxiety

  Anxiety measures an individual's self-reported fear, anxiousness, hyperarousal, and somatic symptoms related to arousal (e.g., racing heart) over the past 7 days.

  Monthly, through study completion (an average of 1 year)

• Changes in the Brief Resilience Scale (BRS)

  A patient's psychological resiliency, their ability to "bounce back or recover from stress" may mediate health outcomes. Psychological resiliency has been associated with patient outcomes following shoulder stabilization surgery within a military population. Individuals who were more resilient had better outcomes (i.e., less time on limited duty status, less attrition from military service) than individuals who were non-resilient. The BRS has moderate test-retest reliability (ICCrange = 0.62-0.69) and has been validated against a number of different scales that measure various aspects of psychological resilience (rrange = -0.68-0.69).

  Monthly, through study completion (an average of 1 year)

• Changes in the Tampa Scale of Kinesiophobia

  The Tampa Scale of Kinesiophobia (TSK-11) measures pain-related fear of movement and re-injury. Kinesiophobia is an important factor in determining who will successfully RTD/A following a musculoskeletal injury. Kinesiophobia may impact sensorimotor function and movement quality in dynamic environments, potentially increasing musculoskeletal injury risk.

  Monthly, through study completion (an average of 1 year)

Study Arms (2)

Concussed Cohort

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

Other: Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk Assessment

Non-Concussed Cohort

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

Other: Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk Assessment

Interventions

Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk Assessment OTHER

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)

Concussed Cohort; Non-Concussed Cohort

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Concussed Cohort: Convenience sample of healthy active duty Service members and physically active civilians who self-report being asymptomatic following a concussion. Non-Concussed Cohort: Convenience sample of non-concussed matched active duty Service members and physically active civilians.

You may qualify if:

• Concussed Cohort
• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• Womack Army Medical Center: collaborator
• University of Georgia: collaborator

Study Sites (3)

University of Georgia

Athens, Georgia, 30602, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

RECRUITING

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

ACTIVE NOT RECRUITING

Related Publications (1)

• Lynall RC, Wasser JG, Brooks DI, Call JA, Hendershot BD, Kardouni JR, Schmidt JD, Mauntel TC. Investigating post-mild traumatic brain injury neuromuscular function and musculoskeletal injury risk: A protocol for a prospective, observational, case-controlled study in service members and active individuals. BMJ Open. 2023 Mar 22;13(3):e069404. doi: 10.1136/bmjopen-2022-069404.

  PMID: 36948547 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Bradford D Hendershot, PhD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

• Robert C Lynall, PhD

  University of Georgia

  STUDY DIRECTOR

• Timothy C Mauntel, PhD

  Womack Army Medical Center

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Facility Research Director

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 17, 2021
• Study Start: October 20, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (3)