Development and Validation of an Instrumented Ankle-foot Orthosis

March 17, 2025 updated by: TOPMED

Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling.

TurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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
      • Québec, 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for Patients questionnaire:

  • Having foot drop

Inclusion Criteria for Clinician questionnaire:

  • Being a clinician who treats foot drop patients

Inclusion Criteria for Gait analysis:

  • Having foot drop

Exclusion Criteria for Gait analysis:

  • Not being able to walk without a cane or a walker
  • Having lower extremity spasticity

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: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gait Analysis
Gait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5).
Device: Instrumented Orthosis
Gait analysis will be performed with the instrumented orthosis as well as the reference system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Temporal parameters
Time Frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait Temporal parameters measured by the instrumented orthosis and the reference system, in seconds, these include the different phase durations(stride, stance and swing).
During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Heel strike angle
Time Frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Heel strike angle measured by the instrumented orthosis and the reference system
During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait Spatial parameters
Time Frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait Spatial parameters measured by the instrumented orthosis and the reference system, in meters, these include the length and width of the stride.
During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait speed
Time Frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait speed measured by the instrumented orthosis and the reference system, in meters per second.
During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

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.

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)

September 13, 2023

Primary Completion (Actual)

September 13, 2023

Study Completion (Actual)

September 13, 2023

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 241_Tur_ApEval

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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