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

Primary Purpose

Hemiparesis, Varus Deformity of Equine Carpus

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Caligaloc
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis focused on measuring stroke, hemiplegia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Swynghedau, CHIRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (CALIGALOC)

Arm Description

Wearing of the Caligaloc orthosis

Outcomes

Primary Outcome Measures

10-meter walk test (in seconds)
Maximum gait velocity, from a standing start

Secondary Outcome Measures

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.
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
Baropodometric analysis during gait
Assessment of the paretic footprint during gait, using the Zebris platform
Gait endurance (2-minute walk test)
Assessment of maximum gait perimeter during a 2mwt
Assessment of walking function
Lower Limb Function assessment scale (LL-FAS, Allart et al. 2015) functional subscores
Tolerability of the wearing of the Caligaloc orthosis assessed by visual analog scale
visual analog scale (0=major discomfort - 10=excellent comfort)

Full Information

First Posted
August 1, 2018
Last Updated
November 3, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03668561
Brief Title
the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
Acronym
CALIGALOC
Official Title
Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Varus Deformity of Equine Carpus
Keywords
stroke, hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (CALIGALOC)
Arm Type
Experimental
Arm Description
Wearing of the Caligaloc orthosis
Intervention Type
Device
Intervention Name(s)
Caligaloc
Intervention Description
15 days of wearing of the Caligaloc orthosis
Primary Outcome Measure Information:
Title
10-meter walk test (in seconds)
Description
Maximum gait velocity, from a standing start
Time Frame
comparison between baseline and 15 days
Secondary Outcome Measure Information:
Title
Assessment of gait temporospatial parameters by GaitRite®
Description
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.
Time Frame
comparison between baseline and 15 days
Title
Posturographic analysis during static upright stance (center of pressure surface)
Description
Assessment of displacements of the center of pressure during quiet upright standing for 30s, using a Zebris platform
Time Frame
comparison between baseline and 15 days
Title
Baropodometric analysis during gait
Description
Assessment of the paretic footprint during gait, using the Zebris platform
Time Frame
comparison between baseline and 15 days
Title
Gait endurance (2-minute walk test)
Description
Assessment of maximum gait perimeter during a 2mwt
Time Frame
comparison between baseline and 15 days
Title
Assessment of walking function
Description
Lower Limb Function assessment scale (LL-FAS, Allart et al. 2015) functional subscores
Time Frame
comparison between baseline and 15 days
Title
Tolerability of the wearing of the Caligaloc orthosis assessed by visual analog scale
Description
visual analog scale (0=major discomfort - 10=excellent comfort)
Time Frame
at 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Etienne Allart, MD
Phone
3 20 44 48 71
Ext
+33
Email
etienne.allart@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne Allart, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Swynghedau, CHI
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Allart, MD,PhD

12. IPD Sharing Statement

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

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