Clinical trial NCT04612478: Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures
Official title: Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Injury
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

.

Eligibility criteria: 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.

Primary outcomes:
measure: Return to work/major activities
timeFrame: 12 months
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: baseline, 3, 6 and12 months
measure: Kinesiophobia
timeFrame: baseline, 3, 6 and12 months
measure: Time to Radiographic Fracture Healing
timeFrame: 3, 6 & 12 months
measure: Muscle Strength
timeFrame: 12 months
measure: Joint Range of Motion (ROM)
timeFrame: 12 months
measure: Resilience
timeFrame: Baseline, 3, 6 & 12 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rachel Seymour, PhD
role: PRINCIPAL_INVESTIGATOR
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