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NCT05780502 · ClinicalTrials.gov registry record

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

A clinical trial of Musculoskeletal Injury, sponsored by Wake Forest University Health Sciences.

Recruiting
Registry status
370
Enrollment target
1
Study location

NCT05780502 is a study of Musculoskeletal Injury that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 370 participants, below the 497-participant average among 15 other Musculoskeletal Injury trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05780502, a study of Musculoskeletal Injury, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.

RECRUITING
Registry status
370 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • BEHAVIORAL Passive Dynamic Brace

Study Locations (1)

North Carolina

  • Carolinas Medical Center - Charlotte

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2015-05-06
Est. Completion 2028-12

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT05780502

The ClinicalTrials.gov registry entry for NCT05780502 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 497-participant average among 15 other Musculoskeletal Injury trials with a reported enrollment target (26% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Musculoskeletal Injury appearing as the primary indexed condition, and to 1 intervention - of which Passive Dynamic Brace is the first listed.

NCT05780502 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT05780502 about?

NCT05780502 is a clinical study titled "Use of an Integrated Orthotic and Rehabilitation Initiative for Treatment of Lower Extremity Musculoskeletal Disorders". 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-b...

What is the current status of trial NCT05780502?

This trial is currently recruiting. The enrollment target is 370 participants. The study started on 2015-05-06. Estimated completion is 2028-12.

What conditions does trial NCT05780502 study?

This clinical trial studies the following conditions: Musculoskeletal Injury.

What interventions are being tested in trial NCT05780502?

The interventions under investigation include: Passive Dynamic Brace (BEHAVIORAL).

Who is sponsoring clinical trial NCT05780502?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05780502 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.