Predictive Models for Spine and Lower Extremity Injury After Discharge From Rehab (MP3-RD)

January 16, 2020 updated by: Dan Rhon, Brooke Army Medical Center

Development of Predictive Models for Lower Extremity, Lumbar, and Thoracic Injury After Discharge From Physical Rehabilitation

The purpose of this study is to develop algorithms that will help predict future injury and/or re-injury after being returned to duty from a musculoskeletal injury. After completion of an episode of care with a physical therapist, the subjects will undergo a battery of physical performance tests and fill out associated surveys. The subjects will then be followed for a year to identify the occurrence/re-occurence of any injuries. Based on the performance on the physical evaluation tests, algorithms will be derived using regression analysis to predict injury.

Subjects will be recruited from the pool of patients that have recently completed physical rehabilitation in physical therapy clinics for their lower extremity or lumbar/thoracic spine injury.

Study Overview

Status

Completed

Conditions

Detailed Description

Subjects will be recruited across 4 medical centers after having completed a regimen of physical therapy for a spine or lower extremity injury. Upon discharge back to full duty, they will be given the opportunity to enroll in the study and undergo a battery of physical performance tests and associated surveys. The subjects will then be followed for a year to identify the occurrence of any injuries. Prediction algorithms will be derived using regression analysis to predict injury based on performance on the physical evaluation tests.

The overall hypothesis is that Service Member performance on a battery of physical performance tests performed upon discharge from care and return to duty, will be able to predict 1) the risk of sustaining any injury as well as 2) reoccurrence of the same injury that they were seeking care for during the year following discharge from rehabilitation. The current assumption is that when a Service Member is discharged from medical care, it has been done based on the expectation that it is appropriate and safe for them to return to function in their operational environment. Because history of prior injury is a well-established risk factor, every single Service Member that is returned to duty after medical care for a musculoskeletal (MSK) injury is already at a higher risk for future injury than his or her non-injured counterpart. The investigators hypothesize that decreased performance on the proposed testing protocol will be related to increase in the risk of 1 year-injury and recurrence of injury. Successfully identifying those at increased risk of recurrence provides the ability for secondary and tertiary prevention programs to optimize return to duty rates. Injury will be defined as any new musculoskeletal injury or the re-occurrence of the same injury during the 1-year surveillance period.

The battery of physical performance tests will include: Selective Functional Movement Assessment (SFMA), Functional Movement Screen (FMS), Upper Quarter Y-balance Test (YBT-UQ), Lower Quarter Y-balance Test (YBT-LQ), Closed Kinetic Chain Dorsiflexion (CKC DF), a Single Hop Test, Triple Hop Test, Triple Crossover Hop Test, Carry Test, and a un-weighted and weighted 300 yard Shuttle Run Test.

Each subject will then also be contacted monthly via a SMS (Short Message Service, e.g. text message) survey for the following year to identify information about additional injury or profile that they may have sustained during the prior period of time. Information about injury will also be calculated from patient chart reviews and Department of Defense healthcare utilization database (claims data). This will provide a robust method in which to capture data injury data regardless of subject availability for follow-up.

Subjects will be dichotomized as injured or non-injured based on the injury surveillance data. Key demographic, physical performance (FMS, YBT, SFMA, Hop Test, Carry test, & Shuttle Run), and self-report measures will be examined for group differences. Potential predictor variables will be entered into a backward stepwise logistic regression model to determine the most accurate set of variables predictive of musculoskeletal injury status.

Risk stratification (low, moderate, or high) will be based on likelihood ratios (LR) associated with the clinical prediction rule for injury outlined above. A positive LR > 10 will place the individual as high risk, a LR between 2 and 10 would place the individual as moderate risk. Those with a positive LR less than 2 will be listed as low risk.

Study Type

Observational

Enrollment (Actual)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Fort Bragg, North Carolina, United States, 28307
        • Womack Army Medical Center
    • Texas
      • Fort Bliss, Texas, United States, 79920
        • William Beaumont Army Medical Center
      • San Antonio, Texas, United States, 78234
        • Brooke Army Medical Center
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Active duty service members that have completed a course of physical therapy for a spine or lower extremity injury, and then discharged to return to full duty.

Description

Inclusion Criteria:

  1. Active duty service member eligible for Tricare benefits
  2. Lower extremity or lumbar/thoracic spine injury is the patient's primary complaint.
  3. Determined fit for duty (cleared to return to work) after completing a course of physical therapy for a lower extremity or lumbar/thoracic spine musculoskeletal injury

Exclusion Criteria:

  1. Individuals planing on leaving the military within the next 10 months.
  2. Trauma or polytrauma that results in amputation of any limbs or appendages.
  3. Pregnancy, or recently pregnant within the last 6 months - subjects that become pregnant during the course of the study will be withdrawn based on the different injury risk factors that are associated with pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Return to Duty after Rehab from Injury
Patients deemed healthy enough to return to full duty without any restrictions after completing a course of rehabilitation for a lumbar/thoracic spine or lower extremity injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injury Occurrence
Time Frame: 1 year
Monthly SMS survey capturing new musculoskeletal injury since the prior survey
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injury-Related Healthcare Utilization
Time Frame: 1 year
Healthcare utilization for musculoskeletal injury taken from the Tricare claims database (MHS Data Repository)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Collaborators

Womack Army Medical Center
William Beaumont Army Medical Center
Madigan Army Medical Center

Investigators

  • Principal Investigator: Daniel Rhon, DSc, Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

September 19, 2018

Study Completion (Actual)

November 19, 2019

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 215032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing must be requested and approved through the Defense Health Agency via a Data Sharing Agreement Application

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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