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Search / Trial NCT05780502

Use of an Integrated Orthotic and Rehabilitation Initiative for Treatment of Lower Extremity Musculoskeletal Disorders

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Mar 9, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people recover from injuries to their legs and feet. It combines a special ankle support device called the Intrepid Dynamic Exoskeletal Orthosis (IDEO) with a tailored rehabilitation program. This approach aims to improve how well patients can move and perform everyday activities after facing various musculoskeletal injuries, such as fractures or surgeries. The study will track participants' progress through tests before, during, and after they complete the program to see how effective this combined treatment is.

To be eligible for the trial, you need to be at least 18 years old and have a customized exoskeletal orthosis fitted to you. You should also be able to give permission for yourself to participate. Unfortunately, if you're pregnant or haven't been fitted with the orthosis, you won't be able to join. If you participate, you can expect close monitoring and support as you go through this unique rehabilitation pathway. The goal is to help improve your recovery and get you back to your daily activities as soon as possible.

Gender

ALL

Eligibility 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

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Charlotte, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Joseph Hsu, MD

Principal Investigator

Carolinas HealthCare

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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