Pre- and Post-neuromusculoskeletal Injury Risk Evaluation for Return-to-Duty Enhancement
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- Womack Army Medical Center
- Study ID
- NCT05111925
- Status
- Recruiting
Conditions
- Musculoskeletal Injuries
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 44 Years
- Healthy Volunteers
- Accepted
Interventions
- PREPARE Initial Clinical Assessment - Post-Injury (up to three iterations) — OTHERParticipants 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 — OTHERParticipants 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
- PREPARE Initial Clinical Assessment - Pre-Injury (one iteration) — OTHERParticipants 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 - Pilot (two iterations) — OTHERParticipants 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
Study Details
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.
Key Dates
- Start date
- Oct 26, 2022
- Status verified
- May 2026
- Primary completion
- May 31, 2027
- Completion
- May 31, 2028
Study Design
- Enrollment
- 2,690 participants (estimated)
Arms
- Arm: Pilot CohortActive duty Service members with no recent history of musculoskeletal injury, no history of musculoskeletal related surgery, and no restrictions on physical activity participation.
- Arm: Uninjured Cohort - Initial AssessmentActive duty Service members who are not currently receiving healthcare for a musculoskeletal injury and who have no physical activity participation restrictions.
- Arm: Injured Cohort - Initial AssessmentActive duty Service members who are receiving conservative treatment for a musculoskeletal injury of the low back or lower extremity.
- Arm: Uninjured Cohort - Optimized AssessmentActive duty Service members who are not currently receiving healthcare for a musculoskeletal injury and who have no physical activity participation restrictions.
- Arm: Injured Cohort - Optimized AssessmentActive duty Service members who are receiving conservative treatment for a musculoskeletal injury of the low back or lower extremity.
Primary Outcome Measure
Number of musculoskeletal injuries (MSKIs) by study participant. [ Time Frame: through study completion, an average of 1 year. ]
Central Contacts
- Timothy C Mauntel, PhD910-849-7226
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | |
| Womack Army Medical Center | Fort Liberty | North Carolina | 28310 |
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