Rehabilitation After Lower Extremity Nailing Trial (ReLENT)
20 augustus 2026 bijgewerkt door: University of Chicago
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
80
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
Formal Physical Therapy (PT)
|
|
Actieve vergelijker: 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.
|
Home Exercise Program (HEP)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Difference in SFMA (Selective Functional Movement Assessment) at 90 days
Tijdsspanne: Baseline, 90 days
|
The Selective Functional Movement Assessment (SFMA) is a functional movement assessment method to observe movement restrictions in individuals.
|
Baseline, 90 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Any difference in hip, knee, and ankle ROM (range of motion) measured with goniometer
Tijdsspanne: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measured in degrees
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in thigh circumference
Tijdsspanne: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measured in cm.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in gait speed
Tijdsspanne: 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.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in 30-second chair stand
Tijdsspanne: 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.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in stair climb power test
Tijdsspanne: Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measure of ability to ascend and descend a flight of stairs.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Any difference in VAS Pain Scale
Tijdsspanne: 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
|
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)
Tijdsspanne: 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.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in PROMIS Physical Function 8b short form
Tijdsspanne: 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.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mary K Erdman, M.D., The University of Chicago Medical Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
1 september 2028
Studie voltooiing (Geschat)
1 september 2028
Studieregistratiedata
Eerst ingediend
20 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
20 augustus 2026
Eerst geplaatst (Werkelijk)
25 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
20 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- IRB25-0850
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
No current plan to share data
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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