CompletedNot Applicable

Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture

United States66 participantsStarted 2022-03-03

Plain-language summary

The purpose of this study is to evaluate speed high intensity interval training (HIIT) walking program following an orthopedic trauma.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-reported physical function

Timeframe: Up to 12 weeks

Self-reported physical function

Timeframe: Up to 19 weeks

Self-reported physical function

Timeframe: 6 months

Self-reported physical function

Timeframe: 12 months

Trial details

NCT IDNCT05274022

SponsorBrian W. Noehren

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-18

View on ClinicalTrials.gov More Femoral Fracture trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.