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NCT04572113 · ClinicalTrials.gov registry record
Comparison of Cervical Motion Restriction and Interface Pressure Between Two Cervical Collars
A clinical trial, sponsored by More Foundation.
- Completed
- Registry status
- 12
- Enrollment target
NCT04572113 is a clinical trial that has completed, run by More Foundation. The registered enrollment target is 12 participants.
The verdict
NCT04572113 has completed, sponsored by More Foundation.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study Summary
Cervical orthoses are used to restrict motion for the purpose of preventing spinal instability following trauma or pre- and post-surgery or to protect from pain. Modern cervical orthoses are able to effectively restrict motion of the head however load is concentrated on areas of occipital tissue and may, with long term wear, lead to tissue breakdown in the form of pressure ulcers. Previous research has shown that the Miami J collar (Össur Americas Foothill Ranch, CA) effectively reduced cervical movement while providing superior pressure relief. As new cervical orthoses are developed and become commercially available it is useful to examine their performance in comparison to existing well-tested devices. DJO Global (Vista, CA) have recently developed a cervical collar. The purpose of this study is to compare the ability of this newly developed collar to restrict cervical range of motion while at the same time limit the tissue interface pressure exerted by the collar on patients when they are in an upright seated or supine position Data will be collected in a fully equipped 3D motion analysis laboratory. Cervical range of motion will be tracked and analyzed. Interface pressures between the head and collar will be measured using custom pressure mats.
Interventions
- DEVICE Cervical collar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-11-30 |
| Est. Completion | 2019-11-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04572113
The ClinicalTrials.gov registry entry for NCT04572113 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is More Foundation, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cervical collar is the first listed.
NCT04572113 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04572113 about?
NCT04572113 is a clinical study titled "Comparison of Cervical Motion Restriction and Interface Pressure Between Two Cervical Collars". Cervical orthoses are used to restrict motion for the purpose of preventing spinal instability following trauma or pre- and post-surgery or to protect from pain. Modern cervical orthoses are able to effectively restrict motion of the head however load is concentrated on areas of occipital tissue and...
What is the current status of trial NCT04572113?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2018-11-30. Estimated completion is 2019-11-02.
What interventions are being tested in trial NCT04572113?
The interventions under investigation include: Cervical collar (DEVICE).
Who is sponsoring clinical trial NCT04572113?
This trial is sponsored by More Foundation, which has 3 total clinical trials registered on ClinicalTrials.gov.
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