Rehabilitation After Lower Extremity Nailing Trial

NCT07783568 | Not Yet Recruiting

• 1 other identifier: IRB25-0850
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Femoral Shaft Fracture; Tibial Shaft Fractures

Keywords

physical therapy; home exercise; femoral shaft fracture; tibial shaft fracture; fracture healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

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

• Any difference in thigh circumference

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

• Any difference in gait speed

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

• Any difference in 30-second chair stand

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

• Any difference in stair climb power test

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

Other Outcomes (3)

• Any difference in VAS Pain Scale

  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)

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

• Any difference in PROMIS Physical Function 8b short form

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

Study Arms (2)

Formal Physical Therapy (PT)

ACTIVE COMPARATOR

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)

Home Exercise Program (HEP)

ACTIVE COMPARATOR

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)

Interventions

Formal Physical Therapy (PT) OTHER

Formal Physical Therapy (PT)

Formal Physical Therapy (PT)

Home Exercise Program (HEP) OTHER

Home Exercise Program (HEP)

Home Exercise Program (HEP)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Officials

• Mary K Erdman, M.D.

  The University of Chicago Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share