What this study is
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.
What's being tested
- PREPARE Initial Clinical Assessment - Pilot (two iterations)
Intervention · 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
- PREPARE Initial Clinical Assessment - Pre-Injury (one iteration)
Intervention · 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 - Post-Injury (up to three iterations)
Intervention · 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
Intervention · 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
Study details
- Official title
- Pre-neuromusculoskeletal Injury Risk Factor Evaluation and Post-neuromusculoskeletal Injury Assessment for Return-to-duty/Activity Enhancement
- Sponsor
- Womack Army Medical Center
- Conditions
- Musculoskeletal Injuries
- Enrolling
- 2,690 people
- Starts
- 2022-10-26
- Est. completion
- 2028-05-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 44 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openWalter Reed National Military Medical Center
Bethesda, Maryland, United States
- Courtney M Butowicz · Contact301-400-1069courtney.m.butowicz.civ@health.mil
RecruitingWomack Army Medical Center
Fort Liberty, North Carolina, United States
- Timothy C Mauntel · Contact910-849-7226timothy.c.mauntel.civ@health.mil
Recruiting
Study team
Sponsor
Womack Army Medical Center
Study ID WRNMMC-2020-0283-001
Principal investigator
Timothy C Mauntel, PhD
Womack Army Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.