- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509819
The Influence of Heel Wedge Properties on Roll-over of the Intrepid Dynamic Exoskeletal Orthosis (IDEO)
January 14, 2019 updated by: Andrea J. Ikeda, Brooke Army Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The proposed study includes a between groups comparison (for Aim 1) and a fully repeated crossover design (for Aim 2).
It will be conducted in the Military Performance Lab (MPL) at the Center for the Intrepid (CFI), Brooke Army Medical Center, Joint Base San Antonio (JBSA)Fort Sam Houston, Texas.
Subjects who use IDEOs will come to the Military Performance Lab for one test session during which they will walk in standardized shoes with six different heel wedges in random order.
Control data will also be collected on able-bodied individuals.
Control subjects will also come to the MPL for one test session in which they will walk using the same standardized shoes.
For all subjects, biomechanical gait data will be collected as the subjects walk along a walkway in the MPL.
This data will be used to calculate roll-over shape, instantaneous radius of curvature, Center of Pressure (COP) velocity, and ankle moment.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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San Antonio, Texas, United States, 78239
- Brooke Army Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
IDEO Group
Inclusion Criteria:
- DEERS (Defense Enrollment Eligibility Reporting System) eligible patients at the CFI
- 18 - 55 years old
- Have a unilateral lower extremity injury resulting in foot/ankle weakness and/or pain
- Currently using an IDEO
- Use of the IDEO for greater than two weeks
- Able to ambulate without an assistive device
- Able to comply with gait analysis
- Able to provide written informed consent
Exclusion Criteria:
- Neurologic, musculoskeletal or other disease state affecting the contralateral limb that limits normal locomotion
- Spinal cord injury or central nervous system pathology
- Medical or psychological disease that would preclude safe gait analysis (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia, etc.)
- Pain level of 4 or greater on a 0-10 scale
- Any open wound or infection on the foot
- Pregnancy
Control Group
Inclusion Criteria:
- DEERS eligible
- 18 - 55 years old
- Have no lower extremity injury which affects normal locomotion
- Able to comply with gait analysis
- Able to provide written informed consent
Control Group Exclusion Criteria:
- Neurologic, musculoskeletal or other disease state that limits normal locomotion
- Previous lower extremity injury requiring surgery (e.g. anterior cruciate ligament tear, femur fracture, etc) or currently affecting normal locomotion
- Any pain that affects normal locomotion
- Any open wound or infection on the foot
- Spinal cord injury or central nervous system pathology
- Medical or psychological disease that would preclude safe gait analysis (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia, etc.)
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Military Performance Lab testing
Subjects who use IDEOs will come to the Military Performance Lab for one test session during which they will walk in standardized shoes with six different foam heel wedges (Heel Cushion Material Bulk (foam) from Kingsley Manufacturing Company) in random order.
Control data will also be collected on able-bodied individuals.
Control subjects will also come to the MPL for one test session in which they will walk using the same standardized shoes.
For all subjects, biomechanical gait data will be collected as the subjects walk along a walkway in the MPL.
This data will be used to calculate roll-over shape, instantaneous radius of curvature, COP velocity, and ankle moment.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Roll-over shape
Time Frame: 2 hours
|
This will be calculated by determining the COP location in the coordinate system of the shank.
The shape will be described by the calculated arc length and best-fit radius of curvature
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2 hours
|
Instantaneous radius of curvature
Time Frame: 2 hours
|
This will be calculated by taking the derivative of the anterior-posterior progression of the COP with respect to the shank angle
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2 hours
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COP velocity
Time Frame: 2 hours
|
This will be calculated by taking the derivative of the COP anterior-posterior position
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2 hours
|
Ankle moment
Time Frame: 2 hours
|
This will be calculated from the Ground Reaction Force (GRF) vector relative to the ankle joint center
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2 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrea J Ikeda, MS, Brooke Army Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
April 25, 2016
Study Completion (Actual)
August 23, 2017
Study Registration Dates
First Submitted
July 27, 2015
First Submitted That Met QC Criteria
July 27, 2015
First Posted (Estimate)
July 28, 2015
Study Record Updates
Last Update Posted (Actual)
January 16, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C2015.017d
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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