Rehabilitation After Lower Extremity Nailing Trial (ReLENT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoral Shaft Fracture; Tibial Shaft Fractures
• Intervention / Treatment: Other: Formal Physical Therapy (PT); Other: Home Exercise Program (HEP)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

1. Polytraumatic injuries that preclude the use of assistive devices
2. Closed head injury limiting cognition
3. Nerve injury resulting in motor deficits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Formal Physical Therapy (PT); Patients will be provided with a standardized prescription for outpatient PT. The details of the prescription have been developed with the University of Chicago Medicine Physical Therapy Department. Treatment will be prescribed for 2 sessions per week for a period of 6 weeks.	Other: Formal Physical Therapy (PT); Formal Physical Therapy (PT)
Active Comparator: Home Exercise Program (HEP); Home exercise program (HEP) instructions will be provided to the HEP cohort and will include standardized exercises divided into three phases. Progress through phases is based on functional criteria and is self-determined.	Other: Home Exercise Program (HEP); Home Exercise Program (HEP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in SFMA (Selective Functional Movement Assessment) at 90 days	The Selective Functional Movement Assessment (SFMA) is a functional movement assessment method to observe movement restrictions in individuals.	Baseline, 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any difference in hip, knee, and ankle ROM (range of motion) measured with goniometer	Measured in degrees	Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Any difference in thigh circumference	Measured in cm.	Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Any difference in gait speed	Measured by timing how long it takes to walk a set distance and dividing the distance by the time.	Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Any difference in 30-second chair stand	Count the number of times the patient comes to a full standing position in 30 seconds from a chair.	Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Any difference in stair climb power test	Measure of ability to ascend and descend a flight of stairs.	Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any difference in VAS Pain Scale	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	Participants will complete the following surveys in-person at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Any difference in OSPRO-YF (Optimal Screening for Prediction of Referral and Outcome-Yellow Flag)	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.	Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Any difference in PROMIS Physical Function 8b short form	The PROMIS Physical Function form is a self-reported questionnaire assessing an individual's capability to perform daily physical activities.	Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Mary K Erdman, M.D., The University of Chicago Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: August 20, 2026
• First Submitted That Met QC Criteria: August 20, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: physical therapy; home exercise; fracture healing; tibial shaft fracture; femoral shaft fracture
• Other Study ID Numbers: IRB25-0850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No