RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom, energy storage and return ankle orthosis proven to improve functional ability when coupled with a customized high-intensity rehabilitation program. The Return to Performance (RTP) clinical pathway is the civilian version of the evidence-based Return To Run (RTR) clinical pathway. Together, the CUSTOMIZED EXOSKELETAL ORTHOSIS and RTP form a novel orthotic and rehabilitation initiative. A diverse group of patients has utilized the pathway to date, including combat wounded Soldiers undergoing complex limb salvage procedures, those with muscle and tendon deficiencies, patients with postoperative nerve palsies, various lower extremity fractures and many others. With this study we are seeking to determine how participation in CUSTOMIZED EXOSKELETAL ORTHOSIS RTP clinical pathway affects patient outcomes as determined by validated functional outcome measures. Subjects will undergo testing before, during and after completion of the clinical pathway.

Official Title

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

Quick Facts

Study Start:2015-05-06
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05780502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Minimum 18 years of age
  2. * Fitted with a customized exoskeletal orthosis device
  3. * Able to provide written informed consent
  1. * Less than 18 years of age
  2. * Self-reported pregnancy
  3. * Not fitted with a customized exoskeletal orthosis
  4. * Unable or unwilling to provide written informed consent

Contacts and Locations

Study Contact

Rachel Seymour, PhD
CONTACT
704-355-6969
Rachel.Seymour@carolinas.org
Christine Churchill, MA
CONTACT
704-355-6947
Christine.Churchill@carolinas.org

Principal Investigator

Joseph Hsu, MD
PRINCIPAL_INVESTIGATOR
Carolinas HealthCare

Study Locations (Sites)

Carolinas Medical Center
Charlotte, North Carolina, 28203
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Joseph Hsu, MD, PRINCIPAL_INVESTIGATOR, Carolinas HealthCare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-05-06
Study Completion Date2025-12

Study Record Updates

Study Start Date2015-05-06
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Musculoskeletal Injury