Femoral Shaft FractureReLENTNCT07783568
Rehabilitation After Lower Extremity Nailing Trial
A study testing Formal Physical Therapy (PT) and Home Exercise Program (HEP) in people with Femoral Shaft Fracture and Tibial Shaft Fractures, run by University of Chicago.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Femoral Shaft Fracture, Tibial Shaft Fractures
- What is being tested?
- Formal Physical Therapy (PT) and Home Exercise Program (HEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 or older
- Unstable femoral or tibial shaft fracture treated with a locked intramedullary nail
- Willing and able to provide informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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
- Being tested
- Formal Physical Therapy (PT), Home Exercise Program (HEP)
- Keywords
- physical therapy, home exercise, femoral shaft fracture, tibial shaft fracture, fracture healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formal Physical Therapy (PT)Other
Formal Physical Therapy (PT)
Home Exercise Program (HEP)Other
Home Exercise Program (HEP)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Home Exercise Program (HEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 90 days
Secondary outcomes (5)
Any difference in hip, knee, and ankle ROM (range of motion) measured with goniometer
Measured in degrees
Measured: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Any difference in thigh circumference
Measured in cm.
Measured: 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: 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: 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: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Shaft FractureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary K Erdman, M.D., Principal investigator, The University of Chicago Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783568
- Sponsor's protocol ID
- IRB25-0850
- Acronym
- ReLENT
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation After Lower Extremity Nailing Trial
- ClinicalTrials.gov ID
- NCT07783568
- Acronym / sponsor ID
- ReLENT / IRB25-0850
- Conditions
- Femoral Shaft Fracture, Tibial Shaft Fractures
- Keywords
- physical therapy, home exercise, femoral shaft fracture, tibial shaft fracture, fracture healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formal Physical Therapy (PT) | Active comparator | Other: 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. |
| Home Exercise Program (HEP) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Unstable femoral or tibial shaft fracture treated with a locked intramedullary nail
- Willing and able to provide informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formal Physical Therapy (PT)Formal Physical Therapy (PT) | Other | Formal Physical Therapy (PT) |
| Home Exercise Program (HEP)Home Exercise Program (HEP) | Other | Home Exercise Program (HEP) |
Primary outcome
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.
5 secondary outcomes
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
Any difference in thigh circumference
Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Any difference in gait speed
Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Any difference in 30-second chair stand
Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Any difference in stair climb power test
Time frame: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. No current plan to share data
Related trials for Femoral Shaft Fracture
Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
Femoral Shaft Fractures, Femur Fractures
Recruiting
Opioid-Free Pain Treatment in Trauma Patients
Femoral Neck Fractures, Intertrochanteric Fractures
RecruitingObservational study
Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture
Fracture Non Union, Fracture Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary K Erdman, M.D. principal investigator
The University of Chicago Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Formal Physical Therapy (PT) and Home Exercise Program (HEP) in people with Femoral Shaft Fracture and Tibial Shaft Fractures, run by University of Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in SFMA (Selective Functional Movement Assessment) at 90 days (time frame: Baseline, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 2 Nov 2026.