Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures
Condition: Musculoskeletal Injury
Study type: Interventional

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

      .
    

Intervention name(s): Self-Directed Exercise Program; Clinic-Based Physical
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment