Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT03335657
Eligibility Criteria:
Inclusion criteria:
1. Ages 18-60 yrs inclusive
2. 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).
3. Injury resulting from a moderate to high energy force (e.g. motor vehicle or motorcycle crash, fall \> 10 ft, gun shot, blunt trauma)
4. 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
5. 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:
1. Non-English speaking
2. 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
3. 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
4. Patients with major amputations of the upper or lower extremities (great toe, thumb, or proximal to the wrist or ankle)
5. Patients who require a Legally Authorized Representative (as defined by an inability to answer the "Evaluation of Give Consent" questions)
6. Patients non-ambulatory pre-injury or due to an associated spinal cord injury
7. History of dementia or Alzheimer's disease based on medical record or patient self-report
8. 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
9. Presence of schizophrenia or other psychotic disorder based on medical record or patient self-report
10. Current alcohol and/or drug addiction based on medical record or patient self-report
11. Severe problems with maintaining follow-up expected (e.g. patients who are incarcerated or homeless)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03335657
Study Brief:
Protocol Section:
NCT03335657