Rehabilitation program to improve recovery for patients with lower leg fractures
Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture
This study tests a special walking program to see if it helps people recovering from lower leg fractures get stronger and recover better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 2 sites (Lexington, Kentucky and 1 other locations) |
| Trial ID | NCT05274022 on ClinicalTrials.gov |
What this trial studies
This study evaluates a high intensity interval training (HIIT) walking program for patients recovering from femoral and tibial shaft fractures that require surgical fixation. The program involves short bursts of high effort walking followed by recovery periods, aiming to enhance functional abilities and strength during rehabilitation. By focusing on this specific orthopedic trauma population, the study seeks to address the challenges of recovery and improve overall patient outcomes. Participants will be recruited during follow-up visits, ensuring they can provide informed consent.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-50 who have sustained an acute orthopedic injury to the femoral or tibial shaft requiring surgical fixation.
Not a fit: Patients with chronic pain, severe traumatic brain injuries, or those who are non-ambulatory prior to the fracture may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance recovery and functional outcomes for patients with lower extremity fractures.
How similar studies have performed: While HIIT has shown success in other clinical populations, this approach is novel within the orthopedic trauma context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to read and speak English * Acute orthopedic injury to the femoral or tibial shaft requiring surgical fixation with an intramedullary rod * Age 18-50 years of age Exclusion Criteria: * History of chronic pain defined as pain lasting more than 3 months and bothersome at least half the days over the past 6 months that started before the fracture * Moderate or severe traumatic brain injury * Initial treatment requiring amputation * Not employed at the time of the accident at least 20 hours per week. * Spinal cord injury * History of schizophrenia, dementia or neurologic disorder with peripheral dysfunction * Non ambulatory or limited ability to walk without an assistive device prior to the fracture * Multiple trauma that prevents early weight bearing * Current Pregnancy * Unable to participate in or complete in-person follow-up visits or therapy sessions * In outpatient Physical Therapy at the start of the intervention * Use of an assistive device to walk for community ambulation at the 10-12 weeks post hospital discharge time point
Where this trial is running
Lexington, Kentucky and 1 other locations
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Brian Noehren, Ph.D. — University of Kentucky
- Study coordinator: Brian Noehren, Ph.D.
- Email: b.noehren@uky.edu
- Phone: 859-218-0581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.