NCT07783568|Not Yet Recruiting
Rehabilitation After Lower Extremity Nailing Trial
ReLENT
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ReLENT
Sponsor study identifier
interventional
80
0 countries
N/A
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 20, 2026
Actual (reported)August 25, 2026
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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
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.
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.
Formal Physical Therapy (PT)
Home Exercise Program (HEP)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mary K Erdman, M.D.
The University of Chicago Medical Center
First Submitted
August 20, 2026
First Posted
August 25, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2028
EstimatedFunctional Outcome and MRI of Muscle Damage Following Nailing Procedure in Femur (Thigh) Fractures Using Different Entry Points
Femoral Pediatric Fractures. Walking Spica Cast vs Synthetic Pants
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 25, 2026
Record last verified: 2026-08
No current plan to share data
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Source: ClinicalTrials.gov.
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