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The Influence of Heel Wedge Properties on Roll-over of the Intrepid Dynamic Exoskeletal Orthosis (IDEO)

NCT02509819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-01-16

No results posted yet for this study

Summary

The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a type of ankle foot orthosis designed to reduce pain and improve function for individuals with foot/ankle pain and/or weakness. Because the IDEO restricts ankle movement, the geometry and mechanics of the device must be designed to allow for a smooth roll-over as the patient walks with the IDEO. The heel wedge, while not physically part of the IDEO, is an integral part of the IDEO-heel wedge-shoe "system". The goal of this research is to determine how heel wedge properties may contribute to the smoothness of roll-over during gait. Insight into the effects of heel wedge properties on roll-over will help optimize the design of the IDEO-heel wedge-shoe "system" and may produce guidelines for the customization of these features.

Conditions

  • Physical Disability

Interventions

DEVICE

Heel Cushion Material Bulk (foam)

The heel wedge is made of a rubber style urethane foam. Heel wedges of specified heights and durometers will be inserted into the standard shoes, one at a time, during the test session only. The heel wedges used during the test session are made of the same foam as the heel wedges that are used clinically.

Sponsors & Collaborators

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Andrea J Ikeda, MS · Brooke Army Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-04-25
Completion
2017-08-23

Countries

  • United States

Study Locations

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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 NCT02509819 on ClinicalTrials.gov