MedTrace Logo

Study of How An Ankle Strap Changes Effects of Insole Treatment for Knee Osteoarthritis

NCT00331110 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2008-01-03

No results posted yet for this 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).

Conditions

  • Medial Compartment Knee Osteoarthritis

Interventions

DEVICE

Laterally-Wedged Insole with Ankle Strapping

DEVICE

Laterally-Weged Insole

Sponsors & Collaborators

  • Physiatric Association of Spine, Sports and Occupational Rehabilitation

    collaborator OTHER

  • Foundation for Physical Medicine and Rehabilitation

    collaborator OTHER

  • University of Iowa

    lead OTHER

Principal Investigators

  • Neil A Segal, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00331110 on ClinicalTrials.gov