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

NCT ID: NCT05163782

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2023-06-28

Brief Summary

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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?

Detailed Description

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Conditions

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Foot Drop

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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People with foot drop

People with left or right foot drop

Group Type EXPERIMENTAL

New ankle foot orthosis with anterior support

Intervention Type DEVICE

New ankle foot orthosis with anterior support developed by Turbomed

Ankle foot orthosis with anterior support

Intervention Type DEVICE

Ankle foot orthosis with anterior support from Turbomed

Ankle foot orthosis from competitor 1

Intervention Type DEVICE

Ankle foot orthosis with posterior support from competitor 1

Ankle foot orthosis from competitor 2

Intervention Type DEVICE

Ankle foot orthosis with posterior support from competitor 2

Interventions

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New ankle foot orthosis with anterior support

New ankle foot orthosis with anterior support developed by Turbomed

Intervention Type DEVICE

Ankle foot orthosis with anterior support

Ankle foot orthosis with anterior support from Turbomed

Intervention Type DEVICE

Ankle foot orthosis from competitor 1

Ankle foot orthosis with posterior support from competitor 1

Intervention Type DEVICE

Ankle foot orthosis from competitor 2

Ankle foot orthosis with posterior support from competitor 2

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turbomed Orthotics Inc.

UNKNOWN

Sponsor Role collaborator

Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

TOPMED

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edith Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

TOPMED

Locations

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TOPMED

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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RD-19-0276_OptOrPi

Identifier Type: -

Identifier Source: org_study_id

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