Rehabilitation After Lower Extremity Nailing Trial (ReLENT)
20 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
80
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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)
|
|
Aktiv komparator: 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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference in SFMA (Selective Functional Movement Assessment) at 90 days
Tidsram: Baseline, 90 days
|
The Selective Functional Movement Assessment (SFMA) is a functional movement assessment method to observe movement restrictions in individuals.
|
Baseline, 90 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Any difference in hip, knee, and ankle ROM (range of motion) measured with goniometer
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Any difference in VAS Pain Scale
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Mary K Erdman, M.D., The University of Chicago Medical Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 september 2028
Avslutad studie (Beräknad)
1 september 2028
Studieregistreringsdatum
Först inskickad
20 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2026
Första postat (Faktisk)
25 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- IRB25-0850
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
No current plan to share data
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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