Femoral Shaft Fracture, Tibial Shaft Fractures
Conditions
Keywords
physical therapy, home exercise, femoral shaft fracture, tibial shaft fracture, fracture healing
Brief 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. 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.
Interventions
OTHERFormal Physical Therapy (PT)
Formal Physical Therapy (PT)
Home Exercise Program (HEP)
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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: 1. Polytraumatic injuries that preclude the use of assistive devices 2. Closed head injury limiting cognition 3. Nerve injury resulting in motor deficits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in SFMA (Selective Functional Movement Assessment) at 90 days | Baseline, 90 days | The Selective Functional Movement Assessment (SFMA) is a functional movement assessment method to observe movement restrictions in individuals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Measured in degrees |
| Any difference in thigh circumference | Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year | Measured in cm. |
| Any difference in gait speed | 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. |
| Any difference in 30-second chair stand | 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. |
| Any difference in stair climb power test | Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year | Measure of ability to ascend and descend a flight of stairs. |
Contacts
PRINCIPAL_INVESTIGATORMary K Erdman, M.D.
The University of Chicago Medical Center
Outcome results
None listed