Pre- and Post-neuromusculoskeletal Injury Risk Evaluation for Return-to-Duty Enhancement

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-44
SponsorWomack Army Medical Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PREPARE Initial Clinical Assessment - Pilot (two iterations)

    Other intervention

    Participants 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 intervention

    Participants 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 intervention

    Participants 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 intervention

    Participants 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

2,690 Participants
are divided into 5 treatment groups
Group A: Pilot Cohort1 intervention
Group B: Uninjured Cohort - Initial Assessment1 intervention
Group C: Injured Cohort - Initial Assessment1 intervention
Group D: Uninjured Cohort - Optimized Assessment1 intervention
Group E: Injured Cohort - Optimized Assessment1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, an average of 1 year.

Secondary outcomes

1

Time to MSKI

The study team will calculate the time to the first MSKI following the PREPARE Clinical Assessment.

Time frame
through study completion, an average of 1 year.
2

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 frame
1 year.
3

Time to Complete the PREPARE Clinical Assessment

The study team will record the time to complete each component of the PREPARE Clinical Assessment.

Time frame
1 year.

Other outcomes

1

Misclassification of MSKI

The study team will calculate the agreement between participant self-reported MSKI counts and medical record reported MSKI counts.

Time frame
1 year.

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