Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures
NCT ID: NCT04612478
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2018-03-14
2023-11-02
Brief Summary
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Detailed Description
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The purpose of this study is to compare the effectiveness and value of clinic-based PT and a home-based, self-directed exercise program (SDEP). The home exercise program will be developed by a team of physical therapists, orthopaedic trauma surgeons and experts in rehabilitation engagement in collaboration with patients recovering from traumatic lower-extremity injuries. The study will also determine which subgroups of individuals based on patient and injury characteristics are the best candidates for a home exercise program.
Hypothesis: The overall hypothesis is that return to work/major activities as well as clinical and functional outcomes and health-related quality of life for patients who receive clinic-based PT will be similar to patients receiving SDEP.
Specific Aim 1: To compare the effectiveness of SDEP, exercise instructions given by physician and clinic-based PT for improving return to work/major activities, clinical and functional/performance outcomes and health-related quality of life in patients following selected lower-extremity fractures.
Specific Aim 2: To determine which sub-groups of patients, based on patient and injury characteristics, are most likely to benefit from SDEP.
Specific Aim 3: To compare the cost-effectiveness of clinic-based PT and SDEP
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Clinic-Based Physical Therapy
Patients will be referred to PT by the orthopaedic surgeon for enrollment into a clinic-based PT program per usual referral patterns at the surgeon's center. Patients will receive services based on their health care benefits defined by his or her insurance plan.
Clinic-Based Physical
Patients will be referred to PT by the orthopaedic surgeon for enrollment into a clinic-based PT program per usual referral patterns at the surgeon's center. Patients will receive services based on their health care benefits defined by his or her insurance plan.
Self-Directed Exercise Program
The full SDEP program, which will be developed by physical therapists, orthopaedic trauma surgeons, and investigators with experience in health behavior change, will be designed to maximize adherence/compliance with the program. The SDEP manual will provide detailed instructions on exercises, such as repetitions, frequency, and required equipment, which can be implemented in the home environment. The basis for the exercise regimen is derived from the American Academy of Orthopaedic Surgeons (AAOS) sample home based exercise program available in handout form. The program provides instructions on exercises, repetitions or duration, frequency, and required equipment which can be implemented in the home environment.
Self-Directed Exercise Program
The full SDEP program, which will be developed by physical therapists, orthopaedic trauma surgeons, and investigators with experience in health behavior change, will be designed to maximize adherence/compliance with the program
Observational
Patients who are unwilling to be randomized will be enrolled in an observational arm of the study. They will be asked to complete all baseline and follow-up assessments, and participation in formal PT or SDEP will be documented.
No interventions assigned to this group
Interventions
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Self-Directed Exercise Program
The full SDEP program, which will be developed by physical therapists, orthopaedic trauma surgeons, and investigators with experience in health behavior change, will be designed to maximize adherence/compliance with the program
Clinic-Based Physical
Patients will be referred to PT by the orthopaedic surgeon for enrollment into a clinic-based PT program per usual referral patterns at the surgeon's center. Patients will receive services based on their health care benefits defined by his or her insurance plan.
Eligibility Criteria
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Inclusion Criteria
* All patients must be English or Spanish competent and able to be followed at the sites for at least 12 months following injury.
Exclusion Criteria
* Bilateral lower-extremity injuries that preclude crutch ambulation
* Associated spine, pelvic, and/or acetabular fractures that otherwise alter weightbearing plan
* Type III B/C open fractures
* Glasgow Coma Scale \<15 at time of discharge
* Major peripheral nerve injury
* Planned admission to a skilled nursing facility or inpatient rehabilitation facility
* Pregnant women
* Patients diagnosed with a Traumatic Brain Injury (TBI) will be excluded from the study.
18 Years
65 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Rachel Seymour, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Carolinas Medical Center
Charlotte, North Carolina, United States
Greenville Health System
Greenville, South Carolina, United States
Countries
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References
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Castillo RC, MacKenzie EJ, Webb LX, Bosse MJ, Avery J; LEAP Study Group. Use and perceived need of physical therapy following severe lower-extremity trauma. Arch Phys Med Rehabil. 2005 Sep;86(9):1722-8. doi: 10.1016/j.apmr.2005.03.005.
Archer KR, Mackenzie EJ, Castillo RC, Bosse MJ; LEAP Study Group. Orthopedic surgeons and physical therapists differ in assessment of need for physical therapy after traumatic lower-extremity injury. Phys Ther. 2009 Dec;89(12):1337-49. doi: 10.2522/ptj.20080200. Epub 2009 Oct 29.
Castillo RC, MacKenzie EJ, Archer KR, Bosse MJ, Webb LX; LEAP Study Group. Evidence of beneficial effect of physical therapy after lower-extremity trauma. Arch Phys Med Rehabil. 2008 Oct;89(10):1873-9. doi: 10.1016/j.apmr.2008.01.032.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00024283
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00082966
Identifier Type: -
Identifier Source: org_study_id
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