Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures
Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures
The purpose of this study is to compare the effectiveness and value of clinic-based physical
 therapy (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.
There is little clinical debate that patients with multiple extremity injuries or injuries
 with associated complex soft tissue damage or nerve deficits benefit from supervised PT.
 Prior research from the LEAP Study examined the impact of PT on patients with high energy
 trauma injuries below the distal femur.1 While the surgeons and PTs differed in their
 assessment of perceived need for PT,2,3 evidence demonstrates the beneficial effect of PT for
 this patient population.4 Research on combat-related lower extremity limb salvage patients
 showed a significant benefit and a higher return-to-duty rate following intense and focused
 rehabilitation combined with an integrated orthotic.5-7 However, the majority of lower
 extremity fractures seen in the military and civilian sectors are not combat related or of
 the severity of the Lower Extremity Assessment Project (LEAP) limb salvage patients and, thus
 may not require intensive, clinic-based, supervised PT treatment. Patients with isolated
 major lower extremity fractures may benefit from a self-guided, home-based post-injury
 exercise program. Studies evaluating home exercise programs for elective orthopaedic
 reconstruction surgery for joint replacement and anterior cruciate ligament (ACL
 )reconstruction have reported equivalent outcomes compared to in-person, supervised PT.8-12
 Because PT resources are critical, limited, and expensive in most civilian centers,
 identifying the patients who would most benefit from utilizing these resources could result
 in savings for both the patients and the health care systems, and lead to more efficient
 access to PT services by the population who needs them the most. In addition to health
 systems benefits, patients able to achieve positive outcomes through a home-based,
 self-directed exercise program would experience flexibility regarding when the exercises are
 performed.

 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

 .
Inclusion Criteria:

 -  Patients aged 18-65 with operative fractures of the femur and tibia (to include distal
 femur (33A, B), plateau (41A, B), pilon (43A, B), and selected ankle injuries (44A,
 B)) presenting to the Orthopaedic Surgeon for either acute care or for the follow-up
 of care performed elsewhere (within 14 days of the injury).

 -  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:

 -  Patients with Injury Severity Score (ISS)>18

 -  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.