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Self-Directed Exercise vs Clinic-Based Therapy for Lower Extremity Fractures
N/A
Waitlist Available
Led By Rachel Seymour, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6 & 12 months
Awards & highlights
Study Summary
This trial will compare the effectiveness and value of two different kinds of post-injury physical therapy: one done in a clinic, and one that patients do themselves at home.
Who is the study for?
This trial is for individuals aged 18-65 who have had surgery for certain leg bone fractures and can follow instructions in English or Spanish. They must be able to attend follow-up visits for a year but cannot join if they need skilled nursing, are pregnant, have severe open fractures, other major injuries that affect walking, severe head injury, high overall injury severity score, major nerve damage or both legs injured preventing crutch use.Check my eligibility
What is being tested?
The study compares two approaches to recovery after leg fractures: traditional clinic-based physical therapy (PT) versus a home-based self-directed exercise program (SDEP). The SDEP will be crafted by experts and aims to see which method is more effective and identify patients who might benefit most from the home exercises.See study design
What are the potential side effects?
Since this trial involves exercise programs rather than medication, side effects may include typical risks associated with physical activity such as muscle soreness, joint pain or potential exacerbation of the fracture site if not performed correctly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6 & 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6 & 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Return to work/major activities
Secondary outcome measures
Change in Quality of Life
Joint Range of Motion (ROM)
Kinesiophobia
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Self-Directed Exercise ProgramExperimental Treatment1 Intervention
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.
Group II: Clinic-Based Physical TherapyExperimental Treatment1 Intervention
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.
Group III: ObservationalActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Self-Directed Exercise Program
2018
N/A
~150
Clinic-Based Physical
2018
N/A
~150
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,033 Total Patients Enrolled
2 Trials studying Musculoskeletal Injuries
370 Patients Enrolled for Musculoskeletal Injuries
Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,704 Total Patients Enrolled
Rachel Seymour, PhD5.01 ReviewsPrincipal Investigator - Wake Forest University Health Sciences
Atrium Health
4 Previous Clinical Trials
1,613 Total Patients Enrolled
5Patient Review
I would highly recommend Rachel Seymour! She was great in every aspect. She was professional and knowledgeable, but also personable and kind. She always made sure to explain things clearly and answer any questions I had.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled positions in this clinical trial for new patients?
"This particular clinical trial, which was originally posted on March 14th 2018 according to clinicaltrials.gov, is not recruiting patients at this time. Although, there are 12 other active trials that potential participants could look into."
Answered by AI
How does one go about joining this clinical trial?
"This study aims to enrol 150 individuals that have suffered musculoskeletal trauma and are between 18-65 years old. Most notably, the following criteria must be met: 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)."
Answered by AI
Are the patients in this trial exclusively middle-aged or older?
"The age group of 18 to 65 is the only one eligible for this trial, however there are 3 similar studies available for those under 18 and 9 other optionsfor patients over 65."
Answered by AI
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