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) — OTHER
    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
    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
  • PREPARE Initial Clinical Assessment - Pre-Injury (one iteration) — OTHER
    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 - Pilot (two iterations) — OTHER
    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

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 Cohort
    Active 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 Assessment
    Active 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 Assessment
    Active duty Service members who are receiving conservative treatment for a musculoskeletal injury of the low back or lower extremity.
  • Arm: Uninjured Cohort - Optimized Assessment
    Active 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 Assessment
    Active 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

Locations (2)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889
Courtney M Butowicz
301-400-1069
Womack Army Medical CenterFort LibertyNorth Carolina28310
Timothy C Mauntel
910-849-7226

Find similar trials in Bethesda, MD

Related Studies