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NCT00331110 · ClinicalTrials.gov registry record · Phase 2
Study of How An Ankle Strap Changes Effects of Insole Treatment for Knee Osteoarthritis
A Phase 2 study, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT00331110 is a Phase 2 study that has completed, run by University of Iowa. The registered enrollment target is 14 participants.
The verdict
NCT00331110, a Phase 2 study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The goal of this project is to assess the effects of an ankle strap on the effectiveness of a laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static and dynamic lower limb biomechanics. Using a repeated measures, modified cross-over design, the following aims and hypotheses will be addressed: Biomechanical Hypotheses 1. Use of the insole with ankle strapping significantly alters hip-knee-ankle (HKA) angle towards 180° or talar valgus angulation. 2. Use of the insole with ankle strapping significantly reduces peak knee external varus moment during gait. 3. Use of the insole with ankle strapping significantly reduces foot external rotation (out-toeing) or widened base during gait analysis. 4. The radiographic HKA angle and tilt angle of the talus will predict knee peak external varus moment during gait. Clinical Hypotheses 1\. The use of an insole with ankle strapping over a two-week period will reduce knee pain (Visual analogue scale, and Knee Osteoarthritis Outcome Survey).
Interventions
- DEVICE Laterally-Wedged Insole with Ankle Strapping
- DEVICE Laterally-Weged Insole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2006-05 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00331110
The ClinicalTrials.gov registry entry for NCT00331110 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Laterally-Wedged Insole with Ankle Strapping is the first listed.
NCT00331110 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00331110 about?
NCT00331110 is a clinical study titled "Study of How An Ankle Strap Changes Effects of Insole Treatment for Knee Osteoarthritis". The goal of this project is to assess the effects of an ankle strap on the effectiveness of a laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static and dynamic lower limb biomechanics. Using a repeated measures, modified cross-over design, the following aims and...
What is the current status of trial NCT00331110?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2006-05. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00331110?
The interventions under investigation include: Laterally-Wedged Insole with Ankle Strapping (DEVICE), Laterally-Weged Insole (DEVICE).
Who is sponsoring clinical trial NCT00331110?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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