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Mind-Body PT boosts recovery after severe leg injuries

NCT ID NCT03335657

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a program called CBPT that combines physical therapy with cognitive-behavioral techniques to help people recover from serious leg injuries. 633 adults with lower extremity injuries participated. The goal was to see if CBPT improves physical function, reduces pain, and helps people return to work or duty better than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

633 people

The number who actually took part.

Started

Jul 2018

Finished

Jul 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Florida Orthopaedic Institute

    Tampa, Florida, 33606, United States

  • Methodist Hospital

    Indianapolis, Indiana, 46202, United States

  • San Antonio Military Medical Center

    San Antonio, Texas, 78434, United States

  • The University of Texas Health Science Center at Houston Medical School

    Houston, Texas, 78229, United States

  • University of Maryland, R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 20742, United States

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States

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