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NCT Number: NCT07783568

Rehabilitation After Lower Extremity Nailing Trial

The goal of this clinical trial is to learn if outpatient physical therapy (PT) results in differing functional outcomes compared to a self-guided home exercise program (HEP) in tibial or femoral nail patients. The hypothesis is that outpatient PT does not result in superior functional outcomes when compared to a self-guided home exercise program. Outpatient physical therapy for mobility and gait training is the current standard of care following lower extremity fractures.

To test this question, patients will be randomized into either PT or HEP group with PT serving as the control. Researchers will compare the PT and HEP groups to see if patient outcomes differ.

People who agree to join the study will be asked to attend 5 visits over one year. During these visits, they will receive surveys and physical assessments. They will also be asked to answer survey questions about their pain, recovery, and therapy through an email survey. The emailed surveys will be weekly for the first 3 months, then every 2 weeks until 6 months, then every 4 weeks until one year. There are 24 emailed surveys total.

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Key information

Conditions

Femoral Shaft Fracture Tibial Shaft Fractures

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Unstable femoral or tibial shaft fracture treated with a locked intramedullary nail
  • Willing and able to provide informed consent

Exclusion criteria

  • Patients with weight-bearing or range of motion restrictions
  • Patients treated surgically more than 3 weeks prior
  • Previously non-ambulatory patients
  • Pre-existing functional deficit of the lower extremities
  • Patients over the age of 60 years
  • Non-English-speaking patients
  • Patients unwilling or unlikely to attend follow-up visits

Patients who sustain:

  • Polytraumatic injuries that preclude the use of assistive devices
  • Closed head injury limiting cognition
  • Nerve injury resulting in motor deficits

Treatment and study plan

Formal Physical Therapy (PT)

Other

Formal Physical Therapy (PT)

Home Exercise Program (HEP)

Other

Home Exercise Program (HEP)

Primary outcomes

  1. Difference in SFMA (Selective Functional Movement Assessment) at 90 days

    Time frame: Baseline, 90 days

    The Selective Functional Movement Assessment (SFMA) is a functional movement assessment method to observe movement restrictions in individuals.

Secondary outcomes

  1. Any difference in hip, knee, and ankle ROM (range of motion) measured with goniometer

    Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year

    Measured in degrees

  2. Any difference in thigh circumference

    Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year

    Measured in cm.

  3. Any difference in gait speed

    Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year

    Measured by timing how long it takes to walk a set distance and dividing the distance by the time.

  4. Any difference in 30-second chair stand

    Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year

    Count the number of times the patient comes to a full standing position in 30 seconds from a chair.

  5. Any difference in stair climb power test

    Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year

    Measure of ability to ascend and descend a flight of stairs.

Other outcomes

  1. Any difference in VAS Pain Scale

    Time frame: Participants will complete the following surveys in-person at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year

    The Visual Analogue Scale (VAS) for pain is a 100 mm line labeled "no pain" at 0 mm and "worst imaginable pain" at 100 mm

  2. Any difference in OSPRO-YF (Optimal Screening for Prediction of Referral and Outcome-Yellow Flag)

    Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year

    The OSPRO-YF is designed to help healthcare practitioners identify pain-related psychological characteristics in outpatient orthopedic settings. As OSPRO-YF summarizes 11 psychological questionnaires, it is not scored like a conventional screening tool. Quartile scores are used instead of cutoff scores for consistency and assessment of a wide range of outpatient orthopedic patients.

  3. Any difference in PROMIS Physical Function 8b short form

    Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year

    The PROMIS Physical Function form is a self-reported questionnaire assessing an individual's capability to perform daily physical activities.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: ReLENT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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