Post-Concussion Musculoskeletal Injury Risks
ConditionMusculoskeletal Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorWalter Reed National Military Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk Assessment
Other interventionParticipants 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)
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: Concussed Cohort1 intervention
Group B: Non-Concussed Cohort1 intervention
Trial outcomes
Primary outcomes
1
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").
Time frame
Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.2
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").
Time frame
Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.3
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").
Time frame
Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.4
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.
Time frame
Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Walter Reed National Military Medical Center
Lead sponsor
Womack Army Medical Center
Collaborator
University of Georgia
Collaborator
Source ClinicalTrials.gov