CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Self-Directed Exercise Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04612478
NCT04612478N/ACompleted

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

Wake Forest University Health Sciences·interventional·Posted Nov 3, 2020·Updated Jan 31, 2024

In Brief

A clinical study evaluating Self-Directed Exercise Program and Clinic-Based Physical for Musculoskeletal Injury. Completed, enrolled 150 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 3, 2020
Enrollment StartMar 14, 2018
Primary CompletionNov 2, 2022
Study CompletionNov 2, 2023
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 5.7 years ago

Interventions

Self-Directed Exercise Programbehavioral

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

Clinic-Based Physicalbehavioral

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.