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

NCT05780502 | Recruiting

• 2 other identifiers: IRB0008225505-15-11E
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Musculoskeletal Injury

Outcome Measures

Primary Outcomes (7)

• Change in patient-reported outcomes measurement information system (PROMIS 29) scores

  The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome.

  baseline, week 0 (time of delivery), 3, 6, 12

• Performance Measure: Self-selected walking velocity (SSWV) over level ground

  Subjects will walk between two floor markers spaced 15m apart on straight, level terrain. They will have a 5m lead-in to achieve a comfortable pace, and the time needed to traverse the next 15m will be recorded. Three trials will be performed for each testing session. Decrement in gait speed is identified as early indicator of reduced physical function in older adults population.20

  baseline, week 0 (time of delivery), 3, 6, 12

• Performance Measure: Timed stair ascent

  Timed stair climbing is often used as an objective measure of mobility and power and has established test-retest reliability in older adults,21 as well as in a young, uninjured active duty population.19 Participants will be instructed to touch every step to the top of the stair case. After completing the ascent and timing has stopped, patients will-come back to the bottom of the stairs in a safe and controlled manner. Participants will be allowed to use the hand rail if needed. Every subject will perform three trials.

  baseline, week 0 (time of delivery), 3, 6, 12

• Performance Measure- 10 meter walk test

  Participants complete a modified 10 meter walk test which involves the subject starting from a standing position, walking 5 meters at a comfortable pace, turning around, and then walking back 5 meters to the original starting point. The test is repeated twice for each subject.

  baseline, week 0 (time of delivery), 3, 6, 12

• Performance Measure- • Four Square Step Test (FSST)

  Participants begin from a seated position and are directed to come to a full standing position without push off assistance from upper extremities and then return to a seated position without upper extremity assist.

  baseline, week 0 (time of delivery), 3, 6, 12

• Performance Measure- Twenty meters Shuttle Run

  The 20-meter shuttle run/walk requires participants to go to a cone 10 meters away, turn around, and come back (a total of 20 meters distance). Participants are told to move between the cones as fast as they safely can, which may be walking or running based on their current functional level. They will perform three trials with at least a 15 second rest break between trials. Subjects will complete three trials.

  baseline, week 0 (time of delivery), 3, 6, 12

• Performance Measure- Modified Stair Ascent & Descend

  Participants will be instructed to touch every step to the top of the stair case. After completing the ascent, they will be instructed to stop, turn around, stop, and descend the stair case. Participants will be allowed to use the hand rail if needed. Every subject will perform two trials. As with the modified 10-meter walk, subjects will hesitate for ½ second with each stop.

  baseline, week 0 (time of delivery), 3, 6, 12

Interventions

Passive Dynamic Brace BEHAVIORAL

Patient receiving the Passive Dynamic Brace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population for this study will be those patients who have sustained a musculoskeletal injury and have been referred to be fitted for CUSTOMIZED EXOSKELETAL ORTHOSIS and RTR clinical pathway.

You may qualify if:

• Minimum 18 years of age
• Fitted with a customized exoskeletal orthosis device
• Able to provide written informed consent

You may not qualify if:

• Less than 18 years of age
• Self-reported pregnancy
• Not fitted with a customized exoskeletal orthosis
• Unable or unwilling to provide written informed consent

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

Study Officials

• Joseph Hsu, MD

  Carolinas HealthCare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Seymour, PhD

CONTACT

704-355-6969; Rachel.Seymour@advocatehealth.org

Christine Churchill, MA

CONTACT

704-355-6947; Christine.Churchill@advocatehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: May 6, 2015
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)