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Trial record 92 of 141 for:    MPL

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

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ClinicalTrials.gov Identifier: NCT02509819
Recruitment Status : Completed
First Posted : July 28, 2015
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea J. Ikeda, Brooke Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Physical Disability Device: Heel Cushion Material Bulk (foam) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Influence of Heel Wedge Properties on Roll-over of the Intrepid Dynamic Exoskeletal Orthosis (IDEO)
Study Start Date : July 2015
Actual Primary Completion Date : April 25, 2016
Actual Study Completion Date : August 23, 2017

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.
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. COP velocity [ Time Frame: 2 hours ]
    This will be calculated by taking the derivative of the COP anterior-posterior position

  4. 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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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509819


Locations
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United States, Texas
Brooke Army Medical Center
San Antonio, Texas, United States, 78239
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
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Principal Investigator: Andrea J Ikeda, MS Brooke Army Medical Center

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Responsible Party: Andrea J. Ikeda, Research Prosthetist, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT02509819     History of Changes
Other Study ID Numbers: C2015.017d
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

Keywords provided by Andrea J. Ikeda, Brooke Army Medical Center:
rehabilitation
IDEO