Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses

NCT ID: NCT03618628

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-24
• Study Completion Date: 2018-04-12

Brief Summary

The purpose of this study is to determine the ability of carbon fiber off loading orthoses to reduce plantar pressure while providing an augmented plantarflexor power to improve walking and function. Results of this study could lead to increased use of carbon fiber off loading orthoses for patients with diabetes, peripheral neuropathy, and foot wounds as a way augmenting wound healing and preventing future recurrences of wounds.

Detailed Description

The long term goal of this research is the successful incorporation of carbon fiber into an off loading device will provide protection to the insensate foot of people with diabetes by reducing localized peak pressures, and thus the risk of recurrence neuropathic foot wounds and fractures, while improving ankle power at push off that will allow individuals with loss of ankle muscle function to walk faster and return to dynamic activities required in their jobs and for full function in the community. The overall goal of this proposal is to determine effects of carbon fiber off loading orthoses (CFO) design characteristics (lay up and geometry of strut) on brace strength, weight, power return capacity, plantar off-loading and participant comfort using FE models, ex-vivo testing and human testing.

First, a CFO will be fabricated using geometry consistent with the current clinical standard. This representative CFO will serve as a baseline from which a finite element (FE) model will be built. The model will be altered as desired to determine the effects of variable design characteristics. The FE model will estimate brace deflection and stress when the CFO is designed with various lay up designs and brace thicknesses. We will use results from the FE model to fabricate a new CFO for study participants.

We will then measure peak plantar pressures during walking while the participants are barefoot, wearing the CFO consistent with current clinical standards, and wearing the new CFO fabricated based on the results of the FE model. We will also measure plantarflexor power during walking while the participants are wearing the CFO consistent with current clinical standards and while wearing the CFO designed based on the results of the FE model. It is believed that the FE model driven CFO design will lead to improved brace strength while reducing plantar pressure compared to barefoot and will have similar plantarflexor power as the CFO based on current clinical standards.

Conditions

Diabetes Mellitus; Peripheral Neuropathy; Orthotic Device

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

People using a CFO

People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.

Group Type: EXPERIMENTAL

Carbon Fiber Off Loading Orthosis (CFO)

Intervention Type: DEVICE

A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.

Interventions

Carbon Fiber Off Loading Orthosis (CFO)

A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Daily life includes a minimum of moderate activity level (variable cadence walking)

2. Have a Gillette or carbon off loading orthosis as a result of diabetes related foot impairments

3. Diagnosis of diabetes mellitus and peripheral neuropathy

4. Ability to ambulate in the community (K-level ≥ 2)

5. Age > 21 years

Exclusion Criteria

1. Unable to ambulate and complete testing required for study participation.

2. Severe foot deformity of the hindfoot or any deformity of the foot with a dislocation resulting in a bony prominence on the plantar/weightbearing surface of the foot.

3. Neurological diseases that affects walking

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mary Hastings, PT, DPT, ATC

Professor of Physical Therapy, Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Hastings, DPT

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

201308105

Identifier Type: -

Identifier Source: org_study_id