About this trial
The purpose of this study is to develop comprehensive and efficient pre- and post- musculoskeletal injury (MSKI) risk assessments for Service members, incorporating both objective and subjective measures. This is a multi-site observational study to identify the pre- and post-MSKI physical and psychosocial factors contributing to MSKI risks and undesired patient outcomes following MSKI. The study hypothesis is that a set of field-expedient clinical assessments can identify Service member specific MSKI risk factors and post-MSKI deficits that contribute to undesired patient outcomes and provide data to guide patient-specific risk mitigation and rehabilitation programs.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Active duty Service members cleared for full physical activity.
18-44 years old
Active duty Service members cleared for full physical activity.
18-44 years old
Disqualifiers
Currently on limited duty status, for any reason.
Unable to read or comprehend the English language.
Pregnant females (will be eligible for participation in the study after the pregnancy)
Currently on limited duty status, for any reason.
Trial population
Pilot Cohort: Convenience sample of healthy adult active duty Service members. Uninjured Cohorts: Convenience sample of healthy active duty Service members without a current musculoskeletal injury. Injured Cohorts: Convenience sample of healthy active duty Service members with a current musculoskeletal injury.
Trial design
Cohort
Prospective
Treatments tested in this trial
PREPARE Initial Clinical Assessment - Pilot (two iterations)
Other interventionParticipants will complete a comprehensive set of clinical assessments that includes semi-automated field-expedient functional movement quality, joint ranges of motion, and psychosocial assessments. Participants will also report the most recent scores received on the appropriate service-specific physical fitness assessment. Functional movement quality assessments: * Two-Minute Walk * Gait * Double Leg Squat * Single Leg Squat * Jump-Landing * Single Leg Triple Hop * Closed Kinetic Chain Upper Extremity Stability Test * Functional Movement Screen Shoulder Clearing Test * Prone Plank * Active Hip Abduction Joint range of motion assessments: * Knee Extension * Hip Abduction * Hip Internal Rotation * Hip External Rotation * Ankle Dorsiflexion Psychosocial assessments: * NIH PROMIS Physical Function, Pain Interference, Depression, \& Anxiety * Tampa Scale of Kinesiophobia
PREPARE Initial Clinical Assessment - Pre-Injury (one iteration)
Other interventionParticipants will complete a comprehensive set of clinical assessments that includes semi-automated field-expedient functional movement quality, joint ranges of motion, and psychosocial assessments. Participants will also report the most recent scores received on the appropriate service-specific physical fitness assessment. Functional movement quality assessments: * Two-Minute Walk * Gait * Double Leg Squat * Single Leg Squat * Jump-Landing * Single Leg Triple Hop * Closed Kinetic Chain Upper Extremity Stability Test * Functional Movement Screening Shoulder Clearing Test * Prone Plank * Active Hip Abduction Joint range of motion assessments: * Knee Extension * Hip Abduction * Hip Internal Rotation * Hip External Rotation * Ankle Dorsiflexion Psychosocial assessments: * NIH PROMIS Physical Function, Pain Interference, Depression, \& Anxiety * Tampa Scale of Kinesiophobia
PREPARE Initial Clinical Assessment - Post-Injury (up to three iterations)
Other interventionParticipants will complete a comprehensive set of clinical assessments that includes semi-automated field-expedient functional movement quality, joint ranges of motion, and psychosocial assessments. Participants will also report thee most recent scores received on the appropriate service-specific physical fitness assessment. Functional movement quality assessments: * Two-Minute Walk * Gait * Double Leg Squat * Single Leg Squat * Jump-Landing * Single Leg Triple Hop * Closed Kinetic Chain Upper Extremity Stability Test * Functional Movement Screening Shoulder Clearing Test * Prone Plank * Active Hip Abduction Joint range of motion assessments: * Knee Extension * Hip Abduction * Hip Internal Rotation * Hip External Rotation * Ankle Dorsiflexion Psychosocial assessments: * NIH PROMIS Physical Function, Pain Interference, Depression, \& Anxiety * Tampa Scale of Kinesiophobia
PREPARE Optimized Clinical Assessment
Other interventionParticipants will complete an optimized set of clinical assessments that may include semi-automated field-expedient functional movement quality, joint ranges of motion, and/or psychosocial assessments. Participants will also report the most recent scores received on the appropriate service-specific physical fitness assessment. Functional movement quality assessments: * Two-Minute Walk * Gait * Double Leg Squat * Single Leg Squat * Jump-Landing * Single Leg Triple Hop * Closed Kinetic Chain Upper Extremity Stability Test * Functional Movement Screening Shoulder Clearing Test * Prone Plank * Active Hip Abduction Joint range of motion assessments: * Knee Extension * Hip Abduction * Hip Internal Rotation * Hip External Rotation * Ankle Dorsiflexion Psychosocial assessments: * NIH PROMIS Physical Function, Pain Interference, Depression, \& Anxiety * Tampa Scale of Kinesiophobia
Treatment groups
Trial outcomes
Primary outcomes
Number of musculoskeletal injuries (MSKIs) by study participant.
Each MSKI that requires a participant to either seek medical attention from a healthcare provider or to not participate in normal physical activity for 1 or more consecutive days will be recorded.
Secondary outcomes
Time to MSKI
The study team will calculate the time to the first MSKI following the PREPARE Clinical Assessment.
Percentage of participants who go on to develop a self-reported MSKI.
The study team will calculate the percentage of participants who sustain a self-reported MSKI during the follow-up period who were also identified as being high-risk based on the PREPARE Clinical Assessment.
Time to Complete the PREPARE Clinical Assessment
The study team will record the time to complete each component of the PREPARE Clinical Assessment.
Other outcomes
Misclassification of MSKI
The study team will calculate the agreement between participant self-reported MSKI counts and medical record reported MSKI counts.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Womack Army Medical Center
Lead sponsor
Walter Reed National Military Medical Center
Collaborator
United States Department of Defense
Collaborator