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

NCT02509819 | Completed

• 1 other identifier: C2015.017d
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rehabilitation; IDEO

Outcome Measures

Primary Outcomes (4)

• Roll-over shape

  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

  2 hours

• Instantaneous radius of curvature

  This will be calculated by taking the derivative of the anterior-posterior progression of the COP with respect to the shank angle

  2 hours

• COP velocity

  This will be calculated by taking the derivative of the COP anterior-posterior position

  2 hours

• Ankle moment

  This will be calculated from the Ground Reaction Force (GRF) vector relative to the ankle joint center

  2 hours

Study Arms (1)

Military Performance Lab testing

EXPERIMENTAL

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.

Device: Heel Cushion Material Bulk (foam)

Interventions

Heel Cushion Material Bulk (foam) DEVICE

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.

Military Performance Lab testing

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• DEERS (Defense Enrollment Eligibility Reporting System) eligible patients at the CFI
• 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

You may not qualify if:

• 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
• DEERS eligible
• years old
• Have no lower extremity injury which affects normal locomotion
• Able to comply with gait analysis
• Able to provide written informed consent
• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78239, United States

Location

Study Officials

• Andrea J Ikeda, MS

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Prosthetist

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 28, 2015
• Study Start: July 1, 2015
• Primary Completion: April 25, 2016
• Study Completion: August 23, 2017
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

US (1)