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

This study is currently recruiting participants.
Verified December 2016 by Dan Rhon, Brooke Army Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02776930
First Posted: May 18, 2016
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Womack Army Medical Center
William Beaumont Army Medical Center
Madigan Army Medical Center
Information provided by (Responsible Party):
Dan Rhon, Brooke Army Medical Center
  Purpose

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.


Condition
Musculoskeletal Injury Spinal Injuries Leg Injuries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Predictive Models for Lower Extremity, Lumbar, and Thoracic Injury After Discharge From Physical Rehabilitation

Resource links provided by NLM:


Further study details as provided by Dan Rhon, Brooke Army Medical Center:

Primary Outcome Measures:
  • Injury Occurrence [ Time Frame: 1 year ]
    Monthly SMS survey capturing new musculoskeletal injury since the prior survey


Secondary Outcome Measures:
  • Injury-Related Healthcare Utilization [ Time Frame: 1 year ]
    Healthcare utilization for musculoskeletal injury taken from the Tricare claims database (MHS Data Repository)


Estimated Enrollment: 480
Study Start Date: January 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776930


Contacts
Contact: Matt Hartshorne, DPT matthew.t.hartshorne.ctr@mail.mil
Contact: Dani Langness, DPT danielle.c.langness.ctr@mail.mil

Locations
United States, North Carolina
Womack Army Medical Center Recruiting
Fort Bragg, North Carolina, United States, 28307
Contact: Matt Hartshorne, DPT       matthew.t.hartshorne.ctr@mail.mil   
Principal Investigator: Darren Hearn, DPT         
United States, Texas
William Beaumont Army Medical Center Recruiting
Fort Bliss, Texas, United States, 79920
Contact: Dani Langness, DPT       danielle.c.langness.ctr@mail.mil   
Principal Investigator: Scott Carow, DSc         
Brooke Army Medical Center Not yet recruiting
San Antonio, Texas, United States, 78234
Contact: Laurel Proulx, DPT    210-916-6100    laurel.e.proulx.ctr@mail.mil   
Principal Investigator: Daniel Rhon, DSc         
Sub-Investigator: Scott Shaffer, PhD         
United States, Washington
Madigan Army Medical Center Not yet recruiting
Tacoma, Washington, United States, 98431
Contact: Angela Bulaon       danielle.c.langness.ctr@mail.mil   
Sponsors and Collaborators
Brooke Army Medical Center
Womack Army Medical Center
William Beaumont Army Medical Center
Madigan Army Medical Center
Investigators
Principal Investigator: Daniel Rhon, DSc Brooke Army Medical Center
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dan Rhon, Director of Physical Therapy, Center for the Intrepid, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT02776930     History of Changes
Other Study ID Numbers: 215032
First Submitted: May 17, 2016
First Posted: May 18, 2016
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sharing must be requested and approved through the Defense Health Agency via a Data Sharing Agreement Application

Keywords provided by Dan Rhon, Brooke Army Medical Center:
Injury Prediction
Return to Work
Injury Prevention

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Injuries
Leg Injuries
Back Injuries