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

Study Overview
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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.

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

Conditions
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Hemiparesis, Varus Deformity of Equine Carpus

Intervention / Treatment
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* Device: Caligaloc


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (CALIGALOC)<br>Wearing of the Caligaloc orthosis | Device: Caligaloc<br>* 15 days of wearing of the Caligaloc orthosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-meter walk test (in seconds) | Maximum gait velocity, from a standing start | comparison between baseline and 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of gait temporospatial parameters by GaitRite® | Specific temporal and spatial parameters of gait will be measured with the GaitRite gait evaluation system: gait cadence, hemiparetic step length, spatial asymmetry, swing and stance times. | comparison between baseline and 15 days | 
| Posturographic analysis during static upright stance (center of pressure surface) | Assessment of displacements of the center of pressure during quiet upright standing for 30s, using a Zebris platform | comparison between baseline and 15 days | 
| Baropodometric analysis during gait | Assessment of the paretic footprint during gait, using the Zebris platform | comparison between baseline and 15 days | 
| Gait endurance (2-minute walk test) | Assessment of maximum gait perimeter during a 2mwt | comparison between baseline and 15 days | 
| Assessment of walking function | Lower Limb Function assessment scale (LL-FAS, Allart et al. 2015) functional subscores | comparison between baseline and 15 days | 
| Tolerability of the wearing of the Caligaloc orthosis assessed by visual analog scale | visual analog scale (0=major discomfort - 10=excellent comfort) | at 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, hemiplegia