Using a custom orthotic and rehabilitation program for lower limb injuries
Use of an Integrated Orthotic and Rehabilitation Initiative for Treatment of Lower Extremity Musculoskeletal Disorders
This study is testing if using a special orthotic along with a focused rehab program can help people with lower limb injuries recover better and improve their performance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 370 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT05780502 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Intrepid Dynamic Exoskeletal Orthosis (IDEO) combined with a high-intensity rehabilitation program known as the Return to Performance (RTP) pathway for patients with lower extremity musculoskeletal disorders. Participants will be assessed before, during, and after their involvement in the RTP pathway to measure improvements in functional outcomes. The study aims to gather data on how this integrated approach impacts recovery and performance in a diverse patient population, including those with complex limb injuries and postoperative conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are fitted with a customized exoskeletal orthosis and can provide informed consent.
Not a fit: Patients who are under 18 years of age, pregnant, or not fitted with a customized exoskeletal orthosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could significantly enhance recovery and functional ability for patients with lower extremity musculoskeletal disorders.
How similar studies have performed: Preliminary research has shown significant improvements in functional performance for similar approaches, indicating potential success for this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minimum 18 years of age * Fitted with a customized exoskeletal orthosis device * Able to provide written informed consent Exclusion Criteria: * Less than 18 years of age * Self-reported pregnancy * Not fitted with a customized exoskeletal orthosis * Unable or unwilling to provide written informed consent
Where this trial is running
Charlotte, North Carolina
- Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Hsu, MD — Carolinas HealthCare
- Study coordinator: Rachel Seymour, PhD
- Email: Rachel.Seymour@advocatehealth.org
- Phone: 704-355-6969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.