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NCT00115401 · ClinicalTrials.gov registry record
Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 35
- Enrollment target
NCT00115401 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 35 participants.
The verdict
NCT00115401 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
Study Summary
This study will collect information on the different ways that people walk, that is, their gait, when they use ankle braces. Patients will visit NIH on at least three and as many as nine separate occasions. A physical therapist will perform a physical examination to determine how patients move, how strong they are and what their comfortable walking speed is. Then patients will sit on a chair while a camera apparatus takes special pictures of their legs, a procedure lasting up to 2 hours. Patients will be asked to return to learn how to walk with the custom Passive Dynamic Ankle-Foot Orthosis (PD-AFO)-a unique ankle brace designed to improve walking ability by providing natural support to the lower limb. Patients 4 and older who are in good health and able to walk repeatedly a distance of 15 meters (approximately 49 feet) independently and unsupervised may be eligible for this study. With this training, patients may return several times to learn how to walk with the brace, but for their protection, they will not be allowed to take it or use it outside the research team's supervision. The researchers will examine the leg to ensure that the brace fits and will ask questions about it. Each training visit will require up to 1.5 hours. When patients have learned to walk with the brace, they will be asked to visit again and walk while scientific pictures are taken of their legs. During the walking test, patients will wear T-shirts and shorts. Patients' arms and legs will be wrapped with a soft, rubber-like material, to allow small plastic reflective balls to be attached. Firm material known as a shell can be attached to the rubber sleeves, with Velcro or a self-sticking bandage. The small balls may also be attached to the skin, with an adhesive. Also, there may be a test of the muscles, through the use of electromyography, or EMG. The test involves attachment of small metal electrodes to the surface of the skin, again with an adhesive. There should not be discomfort with
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2005-06-16 |
| Est. Completion | 2007-10-17 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00115401
The ClinicalTrials.gov registry entry for NCT00115401 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00115401 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00115401 about?
NCT00115401 is a clinical study titled "Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use". This study will collect information on the different ways that people walk, that is, their gait, when they use ankle braces. Patients will visit NIH on at least three and as many as nine separate occasions. A physical therapist will perform a physical examination to determine how patients move, how ...
What is the current status of trial NCT00115401?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2005-06-16. Estimated completion is 2007-10-17.
Who is sponsoring clinical trial NCT00115401?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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