Trials / Completed
CompletedNCT00006438
How Shoes With Rocker Soles Affect Walking
Rocker Sole Kinetics and Kinematics
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (planned)
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
- Sex
- All
- Age
- 40 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to compare how 3 special types of shoes with rocker-shaped soles help people with foot deformities to walk better. This study will use modern gait lab techniques to measure the forces on the bottom of the feet and to examine whether there is any effect higher on the leg from the rocker soles.
Detailed description
The rocker sole is the most commonly prescribed external shoe modification. Use of rocker soles has been based on theoretical considerations and empirical observations with minimal scientific study and validation. With the passage of the therapeutic shoe bill (PL-100-203, section 4072) authorizing Medicare coverage of shoes and shoe modifications for diabetics, it is important to have objective data regarding the effect of rocker soles. This cross-over study will randomize 46 subjects (40 sensate and 6 insensate) to a combination of 3 rocker soles. Patients will be evaluated at baseline and after 20 minutes wearing each rocker sole shoe design to determine the effect of the type of rocker sole on plantar pressure and gait.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Shoes with Rocker Soles |
Timeline
- Start date
- 1997-01-01
- Completion
- 1999-12-01
- First posted
- 2000-11-06
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00006438. Inclusion in this directory is not an endorsement.