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

NCT05111925 | Recruiting

• 2 other identifiers: WRNMMC-2020-0283-001MO220177
• Study Type: observational
• Target: 2,690
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

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.

  through study completion, an average of 1 year.

Secondary Outcomes (3)

• Time to MSKI

  through study completion, an average of 1 year.

• Percentage of participants who go on to develop a self-reported MSKI.

  1 year.

• Time to Complete the PREPARE Clinical Assessment

  1 year.

Other Outcomes (1)

• Misclassification of MSKI

  1 year.

Study Arms (5)

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.

Other: PREPARE Initial Clinical Assessment - Pilot (two iterations)

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.

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

Injured Cohort - Initial Assessment

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

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

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.

Other: PREPARE Optimized Clinical Assessment

Injured Cohort - Optimized Assessment

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

Other: PREPARE Optimized Clinical Assessment

Interventions

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

Pilot Cohort

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

Uninjured Cohort - Initial Assessment

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

Injured Cohort - Initial Assessment

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

Injured Cohort - Optimized Assessment; Uninjured Cohort - Optimized Assessment

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Pilot Cohort
• Active duty Service members cleared for full physical activity.
• years old
• Uninjured Cohorts
• Active duty Service members cleared for full physical activity.
• 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
• years old

You may not qualify if:

• 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)

Sponsors & Collaborators

• Womack Army Medical Center: lead
• Walter Reed National Military Medical Center: collaborator
• United States Department of Defense: collaborator

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

Womack Army Medical Center

Fort Liberty, North Carolina, 28310, United States

RECRUITING

Related Publications (1)

• Butowicz CM, Hendershot BD, Watson NL, Brooks DI, Goss DL, Whitehurst RA, Harvey AD, Helton MS, Kardouni JR, Garber MB, Mauntel TC. Pre-neuromusculoskeletal injury Risk factor Evaluation and Post-neuromusculoskeletal injury Assessment for Return-to-duty/activity Enhancement (PREPARE) in military service members: a prospective, observational study protocol. J Transl Med. 2022 Dec 25;20(1):619. doi: 10.1186/s12967-022-03832-7.

  PMID: 36567311 DERIVED

Study Officials

• Timothy C Mauntel, PhD

  Womack Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy C Mauntel, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: November 8, 2021
• Study Start: October 26, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

US (2)