Recruiting

Observational Study

Sponsor:

Womack Army Medical Center

Code:

NCT05111925

Conditions

Musculoskeletal Injuries

Eligibility Criteria

Sex: All

Age: 18 - 44

Healthy Volunteers: Accepted

Interventions

PREPARE Initial Clinical Assessment - Pilot (two iterations)

PREPARE Initial Clinical Assessment - Pre-Injury (one iteration)

PREPARE Initial Clinical Assessment - Post-Injury (up to three iterations)

PREPARE Optimized Clinical Assessment

Study Details

Brief summary:

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.

Conditions

Musculoskeletal Injuries

Study ID

NCT05111925

Start date

Oct 26, 2022

Status verified date

May, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 44

Healthy Volunteers: Accepted

Inclusion Criteria:

Pilot Cohort

  • Active duty Service members cleared for full physical activity.
  • 18-44 years old

Uninjured Cohorts

  • Active duty Service members cleared for full physical activity.
  • 18-44 years old

Injured Cohorts

  • Active duty Service members receiving conservative treatment exclusively for a musculoskeletal injury affecting the low back or lower extremity.
  • Recruited at any time following presentation to a rehabilitation care facility for care of the MSKI of interest
  • 18-44 years old

Exclusion Criteria:

Pilot Cohort

  • 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)

Uninjured Cohorts

  • Currently on limited duty status, for any reason.
  • Scheduled for a deployment or separation from current unit within the next 12 months.
  • Unable to read or comprehend the English language.
  • Pregnant females (will be eligible for participation in the study after the pregnancy)

Injured Cohorts

  • Unable to read or comprehend the English language.
  • A MSKI within the last 6 months.
  • History of lower extremity or low back musculoskeletal related surgery.
  • History of moderate or severe traumatic brain injury.
  • Pregnant females (will be eligible for participation in the study after the pregnancy)

Study Design

Enrollment

2690 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Injured Cohort - Initial Assessment

Active duty Service members who are receiving conservative treatment for a musculoskeletal injury of the low back or lower extremity.

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.

Injured Cohort - Optimized Assessment

Active duty Service members who are receiving conservative treatment for a musculoskeletal injury of the low back or lower extremity.

Interventions

PREPARE Initial Clinical Assessment - Pilot (two iterations)

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)

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)

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

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

Primary outcome measure

  • Number of musculoskeletal injuries (MSKIs) by study participant. [ Time Frame: through study completion, an average of 1 year. ]

Central Contacts and Locations

Central contacts

Timothy C Mauntel, PhD

910-849-7226timothy.c.mauntel.civ@health.mil

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Courtney M Butowicz

301-400-1069courtney.m.butowicz.civ@health.mil

Womack Army Medical Center

Recruiting

Fort Liberty, North Carolina, United States, 28310

Contacts

Timothy C Mauntel

910-849-7226timothy.c.mauntel.civ@health.mil

More Information

Sponsor

Womack Army Medical Center

Last update posted

Jun 3, 2026

Last verified

May, 2026

Keywords

  • musculoskeletal injury
  • biomechanics
  • movement assessment
  • neuromuscular control
  • patient reported outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Womack Army Medical Center on 2026-06-03.