Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop

September 13, 2023 updated by: TOPMED

The objective of this research is to compare the new ankle foot orthosis (AFO) with prior support developed by Turbomed, with the AFO with posterior support from Turbomed as well as two competing AFOs currently on the market.

With this research, we seek to answer the following questions:

  • Is the new AFO as biomechanically efficient as the AFOs currently on the market?
  • Is the new AFO more comfortable than the AFO currently on the market?
  • Is the new AFO easier to put on and attach than the AFOs currently on the market?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1S1C1
        • TOPMED

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Foot drop following surgery or an accident (functional calf, without contracture and not spastic)
  • Foot drop following a Cerebral Vascular Accident (with or without spasticity, mild to moderate)
  • Ability to stand and walk alone without technical assistance
  • Ability to communicate comfort/discomfort

Exclusion Criteria:

  • Sore to one of the feet

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: People with foot drop
People with left or right foot drop
Device: New ankle foot orthosis with anterior support
New ankle foot orthosis with anterior support developed by Turbomed
Device: Ankle foot orthosis with anterior support
Ankle foot orthosis with anterior support from Turbomed
Device: Ankle foot orthosis from competitor 1
Ankle foot orthosis with posterior support from competitor 1
Device: Ankle foot orthosis from competitor 2
Ankle foot orthosis with posterior support from competitor 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee flexion angle during gait
Time Frame: At delivery
Maximum, minimum and range of motion of the knee flexion angle during gait.
At delivery
Hip flexion angle during gait
Time Frame: At delivery
Maximum, minimum and range of motion of the hip flexion angle during gait.
At delivery
Minimum foot clearance
Time Frame: At delivery
Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing.
At delivery
Comfort of participants with orthosis
Time Frame: At delivery
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
At delivery
Easy to put on orthosis
Time Frame: At delivery
Easy to put on is measured with a Likert scale from 1 (very difficult) to 5 (very easy).
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TOPMED

Collaborators

Natural Sciences and Engineering Research Council, Canada
Turbomed Orthotics Inc.

Investigators

  • Principal Investigator: Edith Martin, PhD, TOPMED

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 (Actual)

July 19, 2021

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

June 28, 2023

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD-19-0276_OptOrPi

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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