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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03668561
Acronym
CALIGALOC
Enrollment
5
Registered
2018-09-12
Start date
2019-02-22
Completion date
2021-11-18
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiparesis, Varus Deformity of Equine Carpus

Keywords

stroke, hemiplegia

Brief summary

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

Interventions

DEVICECaligaloc

15 days of wearing of the Caligaloc orthosis

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
10-meter walk test (in seconds)comparison between baseline and 15 daysMaximum gait velocity, from a standing start

Secondary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATOREtienne Allart, MD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026