Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 3
- 主要终点
- Changes in Single Leg Hop Kinematic and Kinetic Measures
研究概览
简要总结
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.
详细描述
Musculoskeletal injuries are the greatest unsolved public health problem facing the military and significantly diminish Service member's medical readiness. MSKI affect 800,000 Service members and result in 25 million limited-duty days annually. Additionally, among civilians peers, sport-related MSKI affect as many as 12 million people annually. In total, MSKI place a significant burden on military and civilian populations, with a combined financial burden of more than $980 billion per year in the US alone.
Traumatic brain injuries (TBI), specifically concussions a mild form of TBI, have been classified by the National Institutes of Health and Centers for Disease Control as a "serious health problem" in the US. TBIs have impacted more than 350,000 Service members in the past 19 years. Concussions negatively affect individuals' quality of life, as assessed by patient report outcome (PRO) psychosocial measures, including worse scores for measures of anxiety, depression, fatigue, anger, and pain immediately following concussion, as compared to when they are cleared to return-to-duty/activity (RTD/A).
Musculoskeletal injury (MSKI) risk is increased following RTD/A after concussion. However, despite the well-documented increased MSKI risk following concussion, the underlying neuromuscular mechanisms contributing to this increased risk have yet to be definitively determined. The underlying mechanism contributing to increased MSKI risk is likely a multifaceted issue that requires a comprehensive study to identify all of the factors.
Understanding the neuromuscular control deficits that persist after concussion and how these deficits change over time (longitudinally) will greatly expand the existing knowledge of why individuals are at greater MSKI risk following concussion. Thus, the overall objective is to elucidate the neuromuscular control mechanisms that contribute to increase MSKI risk following concussion so that effective MSKI risk mitigation strategies can be developed. The study team hypothesizes that concussed individuals will display aberrant neuromuscular control function that increases MSKI risk, as compared to non-concussed controls.
This study will address the following specific aims:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •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
研究组 & 干预措施
Non-Concussed Cohort
Gender, age, occupation, and physical activity matched active duty Service Members and physically active civilians who have not sustained a concussion.
干预措施: Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk Assessment (Other)
Concussed Cohort
Active duty Service Members and physically active civilians who have self-reported as asymptomatic post-concussion.
干预措施: Post-Concussion Neuromuscular Function and Musculoskeletal Injury Risk Assessment (Other)
结局指标
主要结局
Changes in Single Leg Hop Kinematic and Kinetic Measures
时间窗: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.
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").
Changes in Single-Task Gait Kinematic and Kinetic Measures
时间窗: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.
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.
Changes in NIH-PROMIS Physical Function
时间窗: Monthly, through study completion (an average of 1 year)
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.
Changes in Muscular Ramp Contraction Measurements
时间窗: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.
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.
Changes in NIH-PROMIS Pain Interference
时间窗: Monthly, through study completion (an average of 1 year)
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.
Changes in NIH-PROMIS Depression
时间窗: Monthly, through study completion (an average of 1 year)
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.
Changes in Jump-Landing Kinematic and Kinetic Measures
时间窗: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.
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").
Changes in Interpolated Twitch Technique Measurements
时间窗: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.
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).
Changes in Closed-Chain Proprioception
时间窗: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.
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).
Changes in Anticipated Cut Kinematic and Kinetic Measures
时间窗: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.
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").
Changes in Dual-Task Gait Kinematic and Kinetic Measures
时间窗: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.
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.
Changes in Passive Joint Repositioning
时间窗: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing,
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).
Changes in Light Touch Sensation
时间窗: Initial testing after reporting asymptomatic post-concussion, 6-Weeks post-initial testing, and 12-Weeks post-initial testing.
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.
Changes in Self-Reported Musculoskeletal Injuries
时间窗: Monthly, through study completion (an average of 1 year)
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.
Changes in NIH-PROMIS Anxiety
时间窗: Monthly, through study completion (an average of 1 year)
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.
Changes in the Brief Resilience Scale (BRS)
时间窗: Monthly, through study completion (an average of 1 year)
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).
Changes in the Tampa Scale of Kinesiophobia
时间窗: Monthly, through study completion (an average of 1 year)
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.
次要结局
未报告次要终点
研究者
Bradford Hendershot
Facility Research Director
Walter Reed National Military Medical Center