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

Not Applicable

• Conditions: Hemiparesis; Varus Deformity of Equine Carpus

• Registration Number: NCT03668561
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Study Start: 2019-02-22
• Status Verified: 2022-08
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
10-meter walk test (in seconds)	comparison between baseline and 15 days	Maximum gait velocity, from a standing start

Secondary Outcome Measures

Name	Time	Method
Assessment of gait temporospatial parameters by GaitRite®	comparison between baseline and 15 days	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.
Baropodometric analysis during gait	comparison between baseline and 15 days	Assessment of the paretic footprint during gait, using the Zebris platform
Gait endurance (2-minute walk test)	comparison between baseline and 15 days	Assessment of maximum gait perimeter during a 2mwt
Tolerability of the wearing of the Caligaloc orthosis assessed by visual analog scale	at 15 days	visual analog scale (0=major discomfort - 10=excellent comfort)
Assessment of walking function	comparison between baseline and 15 days	Lower Limb Function assessment scale (LL-FAS, Allart et al. 2015) functional subscores
Posturographic analysis during static upright stance (center of pressure surface)	comparison between baseline and 15 days	Assessment of displacements of the center of pressure during quiet upright standing for 30s, using a Zebris platform

Trial Locations

Locations (1)

Hôpital Swynghedau, CHI; 🇫🇷 Lille, France