Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses

NCT03618628 | Completed Results

• 1 other identifier: 201308105
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Peripheral Neuropathy; Orthotic Device

Outcome Measures

Primary Outcomes (1)

• Peak Plantar Pressure

  Plantar pressure during walking while the participant wears the brace fabricated based on the finite element (FE) model compared to 1) the brace fabricated based on current clinical standards and 2) barefoot.

  Participant was tested in new brace (based on FE model) after wearing for 1 week.

Study Arms (1)

People using a CFO

EXPERIMENTAL

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.

Device: Carbon Fiber Off Loading Orthosis (CFO)

Interventions

Carbon Fiber Off Loading Orthosis (CFO) 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.

People using a CFO

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daily life includes a minimum of moderate activity level (variable cadence walking)
• Have a Gillette or carbon off loading orthosis as a result of diabetes related foot impairments
• Diagnosis of diabetes mellitus and peripheral neuropathy
• Ability to ambulate in the community (K-level ≥ 2)
• Age \> 21 years

You may not qualify if:

• Unable to ambulate and complete testing required for study participation.
• 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.
• Neurological diseases that affects walking

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Mary Hastings
• Organization: Washington University School of Medicine

hastingsmk@wustl.edu

3142861433

Study Officials

• Mary Hastings, DPT

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy, Orthopaedic Surgery

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 7, 2018
• Study Start: May 24, 2016
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: May 13, 2019
• Results First Posted: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)