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

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ClinicalTrials.gov Identifier: NCT03668561
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hemiparesis Varus Deformity of Equine Carpus Device: Caligaloc Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Treatment (CALIGALOC)
Wearing of the Caligaloc orthosis
Device: Caligaloc
15 days of wearing of the Caligaloc orthosis




Primary Outcome Measures :
  1. 10-meter walk test (in seconds) [ Time Frame: comparison between baseline and 15 days ]
    Maximum gait velocity, from a standing start


Secondary Outcome Measures :
  1. Assessment of gait temporospatial parameters by GaitRite® [ Time Frame: 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.

  2. Posturographic analysis during static upright stance (center of pressure surface) [ Time Frame: comparison between baseline and 15 days ]
    Assessment of displacements of the center of pressure during quiet upright standing for 30s, using a Zebris platform

  3. Baropodometric analysis during gait [ Time Frame: comparison between baseline and 15 days ]
    Assessment of the paretic footprint during gait, using the Zebris platform

  4. Gait endurance (2-minute walk test) [ Time Frame: comparison between baseline and 15 days ]
    Assessment of maximum gait perimeter during a 2mwt

  5. Assessment of walking function [ Time Frame: comparison between baseline and 15 days ]
    Lower Limb Function assessment scale (LL-FAS, Allart et al. 2015) functional subscores

  6. Tolerability of the wearing of the Caligaloc orthosis assessed by visual analog scale [ Time Frame: at 15 days ]
    visual analog scale (0=major discomfort - 10=excellent comfort)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668561


Contacts
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Contact: Etienne Allart, MD 3 20 44 48 71 ext +33 etienne.allart@chru-lille.fr

Locations
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France
Hôpital Swynghedau, CHI Recruiting
Lille, France
Principal Investigator: Etienne Allart, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Etienne Allart, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03668561    
Other Study ID Numbers: 2017_01
2017-A02098-45 ( Other Identifier: ID-RCB number, ANSM )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
stroke
hemiplegia
Additional relevant MeSH terms:
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Paresis
Neurologic Manifestations
Nervous System Diseases