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

Hemiparesis Clinical Trial

— CALIGALOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03668561
• Other study ID #: 2017_01
• Secondary ID: 2017-A02098-45
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: University Hospital, Lille
• Contact: Etienne Allart, MD
• Phone: 3 20 44 48 71
• Email: etienne.allart[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Varus Deformity of Equine Carpus

Intervention

Device:
• Caligaloc
15 days of wearing of the Caligaloc orthosis

Locations

Country	Name	City	State
France	Hôpital Swynghedau, CHI	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10-meter walk test (in seconds)	Maximum gait velocity, from a standing start	comparison between baseline and 15 days
Secondary	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
Secondary	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
Secondary	Baropodometric analysis during gait	Assessment of the paretic footprint during gait, using the Zebris platform	comparison between baseline and 15 days
Secondary	Gait endurance (2-minute walk test)	Assessment of maximum gait perimeter during a 2mwt	comparison between baseline and 15 days
Secondary	Assessment of walking function	Lower Limb Function assessment scale (LL-FAS, Allart et al. 2015) functional subscores	comparison between baseline and 15 days
Secondary	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