the Effect of the CALIGALOC Orthosis on Standing and Walk... | NCT03668561

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

NCT03668561

Sponsor

University Hospital, Lille

Status

Terminated

Last Update Posted

May 22, 2026Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Hemiparesis
Varus Deformity of Equine Carpus

Interventions

Caligaloc

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-A02098-45	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID

Expanded Access Info

Start Date

Feb 22, 2019Actual

Primary Completion Date

Nov 18, 2021Actual

Completion Date

Nov 18, 2021Actual

First Submitted Date

Aug 1, 2018

First Submission Date that Met QC Criteria

Sep 11, 2018

First Posted Date

Sep 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment (CALIGALOC)	Experimental	Wearing of the Caligaloc orthosis	Device: Caligaloc

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caligaloc	Device	15 days of wearing of the Caligaloc orthosis	Treatment (CALIGALOC)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Etienne Allart, MD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Swynghedau, CHI		Lille			France

Condition Browse Module

MeSH Terms

ID	Term
D010291	Paresis
D020521	Stroke
D006429	Hemiplegia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided