Recruiting

Integrated Orthotic Treatment

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05780502

Conditions

Musculoskeletal Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Passive Dynamic Brace

Study Details

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

Study ID

NCT05780502

Start date

May 6, 2015

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

370 participants

Anticipated

Interventions and Outcome Measures

Interventions

Passive Dynamic Brace

Patient receiving the Passive Dynamic Brace

Primary outcome measure

  • Change in patient-reported outcomes measurement information system (PROMIS 29) scores [ Time Frame: baseline, week 0 (time of delivery), 3, 6, 12 ]
  • Performance Measure: Self-selected walking velocity (SSWV) over level ground [ Time Frame: baseline, week 0 (time of delivery), 3, 6, 12 ]
  • Performance Measure: Timed stair ascent [ Time Frame: baseline, week 0 (time of delivery), 3, 6, 12 ]
  • Performance Measure- 10 meter walk test [ Time Frame: baseline, week 0 (time of delivery), 3, 6, 12 ]
  • Performance Measure- • Four Square Step Test (FSST) [ Time Frame: baseline, week 0 (time of delivery), 3, 6, 12 ]
  • Performance Measure- Twenty meters Shuttle Run [ Time Frame: baseline, week 0 (time of delivery), 3, 6, 12 ]
  • Performance Measure- Modified Stair Ascent & Descend [ Time Frame: baseline, week 0 (time of delivery), 3, 6, 12 ]

Central Contacts and Locations

Locations

Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Principal Investigator:

Joseph R Hsu, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-03-12.