Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures

NCT04612478 | Completed

• 2 other identifiers: IRB00082966Pro00024283
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Musculoskeletal Injury

Outcome Measures

Primary Outcomes (1)

• Return to work/major activities

  Measured through the rate of return to work/duty 12 months post discharge using the Work Productivity and Activity Impairment Questionnaire (WPAI)

  12 months

Secondary Outcomes (6)

• Change in Quality of Life

  baseline, 3, 6 and12 months

• Kinesiophobia

  baseline, 3, 6 and12 months

• Time to Radiographic Fracture Healing

  3, 6 & 12 months

• Muscle Strength

  12 months

• Joint Range of Motion (ROM)

  12 months

Study Arms (3)

Clinic-Based Physical Therapy

OTHER

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.

Behavioral: Clinic-Based Physical

Self-Directed Exercise Program

OTHER

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.

Behavioral: Self-Directed Exercise Program

Observational

NO INTERVENTION

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.

Interventions

Self-Directed Exercise Program BEHAVIORAL

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

Self-Directed Exercise Program

Clinic-Based Physical BEHAVIORAL

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 Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (2)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Related Publications (24)

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Study Officials

• Rachel Seymour, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: November 3, 2020
• Study Start: March 14, 2018
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

US (2)