the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus

NCT ID: NCT03668561

Last Updated: 2022-11-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2022-12-31

Brief Summary

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To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.

Detailed Description

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Conditions

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Hemiparesis Varus Deformity of Equine Carpus

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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Treatment (CALIGALOC)

Wearing of the Caligaloc orthosis

Group Type EXPERIMENTAL

Caligaloc

Intervention Type DEVICE

15 days of wearing of the Caligaloc orthosis

Interventions

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Caligaloc

15 days of wearing of the Caligaloc orthosis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hemiparesis at \> 3 months (whatever the etiology)
* varus or equinovarus foot disturbing the stance phase of gait
* Able to walk at least 10m, with or without assistive device

Exclusion Criteria

* unable to walk 10m
* Botulinum toxin injection less than 3 months before inclusion
* history of neurological or locomotor pathology in addition to the etiology of hemiparesis
* Severe comprehension troubles
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Etienne Allart, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Swynghedau, CHI

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Etienne Allart, MD

Role: CONTACT

3 20 44 48 71 ext. +33

Other Identifiers

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2017-A02098-45

Identifier Type: OTHER

Identifier Source: secondary_id

2017_01

Identifier Type: -

Identifier Source: org_study_id

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