Development and Validation of an Instrumented Ankle-foot Orthosis

NCT ID: NCT06115161

Last Updated: 2025-03-20

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-13

Study Completion Date

2023-09-13

Brief Summary

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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.

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

Trial with condition crossover
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Gait Analysis

Gait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5).

Group Type EXPERIMENTAL

Instrumented Orthosis

Intervention Type DEVICE

Gait analysis will be performed with the instrumented orthosis as well as the reference system.

Interventions

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Instrumented Orthosis

Gait analysis will be performed with the instrumented orthosis as well as the reference system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Having foot drop


* Being a clinician who treats foot drop patients


* Having foot drop

Exclusion Criteria

* Not being able to walk without a cane or a walker
* Having lower extremity spasticity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

Turbomed Orthotics Inc.

UNKNOWN

Sponsor Role collaborator

TOPMED

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TOPMED

Québec, , Canada

Site Status

Countries

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Canada

Other Identifiers

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241_Tur_ApEval

Identifier Type: -

Identifier Source: org_study_id

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