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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: Completed Phase 2 study, sponsored by University of Iowa.
NCT00331110 is a Phase 2 study that has completed, run by University of Iowa. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00331110 record still lists
NCT00331110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Laterally-Wedged Insole with Ankle Strapping is the first listed.
NCT00331110 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00331110's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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