Rehabilitation After Lower Extremity Nailing Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Unstable femoral or tibial shaft fracture treated with a locked intramedullary nail
Willing and able to provide informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Formal Physical Therapy (PT)
Other interventionFormal Physical Therapy (PT)
Home Exercise Program (HEP)
Other interventionHome Exercise Program (HEP)
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Formal Physical Therapy (PT)Active comparator 1 intervention
Group B: Home Exercise Program (HEP)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 90 daysSecondary outcomes
1
Any difference in hip, knee, and ankle ROM (range of motion) measured with goniometer
Measured in degrees
Time frame
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year2
Any difference in thigh circumference
Measured in cm.
Time frame
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year3
Any difference in gait speed
Measured by timing how long it takes to walk a set distance and dividing the distance by the time.
Time frame
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year4
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.
Time frame
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 yearOther outcomes
1
Any difference in VAS Pain Scale
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
Time frame
Participants will complete the following surveys in-person at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year2
Any difference in OSPRO-YF (Optimal Screening for Prediction of Referral and Outcome-Yellow Flag)
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.
Time frame
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year3
Any difference in PROMIS Physical Function 8b short form
The PROMIS Physical Function form is a self-reported questionnaire assessing an individual's capability to perform daily physical activities.
Time frame
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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