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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: Recruiting study of Musculoskeletal Injury, sponsored by Wake Forest University Health Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL Passive Dynamic Brace
Study Locations (1)
North Carolina
- Carolinas Medical Center - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2015-05-06 |
| Est. Completion | 2028-12 |
What NCT05780502 shows while recruiting
NCT05780502 is an observational study that tracks outcomes without assigning an intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, below the 497-participant average among 15 other Musculoskeletal Injury trials with a reported enrollment target (26% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Musculoskeletal Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05780502's enrollment target sits among peer trials
370 3rd of 15 higher than 13 of 15 other Musculoskeletal Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Musculoskeletal Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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