Status:
COMPLETED
Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)
Lead Sponsor:
Major Extremity Trauma Research Consortium
Conditions:
Lower Extremity Injury
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The goal of the CBPT study is to determine the efficacy of the CBPT program for improving outcomes in service members and civilians at-risk for poor outcomes following traumatic lower-extremity injury...
Detailed Description
Following extremity injury, referral (and direct access) to physical therapy (PT) is considered standard of care. And, while PT strategies are commonly impairment focused, clinicians across multiple s...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Ages 18-60 yrs inclusive
- Patients with at least one acute orthopaedic injury to the lower extremities or pelvis/acetabulum (determination based on information available at the time of enrollment).
- Injury resulting from a moderate to high energy force (e.g. motor vehicle or motorcycle crash, fall \> 10 ft, gun shot, blunt trauma)
- Patients receiving operative fixation for one or more acute orthopaedic injuries at a participating hospital. Patients should be recruited at the time of primary injury, not revision or complication surgery
- Presence of psychosocial risk factors for poor outcomes (defined as a score greater than 30 on the Pain Catastrophizing Scale (PCS) or a score equal to or greater than 39 on the Tampa Scale for Kinesiophobia (TSK) or a score equal to or less than 40 on the Pain Self Efficacy Scale (PSES)). These risk factors will be identified between 2 and 8 weeks after hospital discharge.
- Exclusion criteria:
- Non-English speaking
- Patients who are unable to start the program within 12 weeks of discharge from hospital because of multiple readmission, admission to a rehabilitation facility, or other extenuating circumstances
- Patients with moderate or severe traumatic brain injury (TBI), as evidenced by intracranial hemorrhage present on admission CT. If no CT performed, patient assumed not to have moderate or severe TBI
- Patients with major amputations of the upper or lower extremities (great toe, thumb, or proximal to the wrist or ankle)
- Patients who require a Legally Authorized Representative (as defined by an inability to answer the "Evaluation of Give Consent" questions)
- Patients non-ambulatory pre-injury or due to an associated spinal cord injury
- History of dementia or Alzheimer's disease based on medical record or patient self-report
- History of neurological disorder, disease or event, resulting in prior cognitive and/or physical impairment, such as prior TBI or stroke based on medical record or patient self-report
- Presence of schizophrenia or other psychotic disorder based on medical record or patient self-report
- Current alcohol and/or drug addiction based on medical record or patient self-report
- Severe problems with maintaining follow-up expected (e.g. patients who are incarcerated or homeless)
Exclusion
Key Trial Info
Start Date :
July 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2021
Estimated Enrollment :
633 Patients enrolled
Trial Details
Trial ID
NCT03335657
Start Date
July 18 2018
End Date
July 18 2021
Last Update
September 26 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida Orthopaedic Institute
Tampa, Florida, United States, 33606
2
Methodist Hospital
Indianapolis, Indiana, United States, 46202
3
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 20742
4
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889