- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03668561
the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus (CALIGALOC)
November 3, 2022 updated by: University Hospital, Lille
Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Etienne Allart, MD
- Phone Number: +33 3 20 44 48 71
- Email: etienne.allart@chru-lille.fr
Study Locations
-
-
-
Lille, France
- Recruiting
- Hôpital Swynghedau, CHI
-
Principal Investigator:
- Etienne Allart, MD,PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (CALIGALOC)
Wearing of the Caligaloc orthosis
|
15 days of wearing of the Caligaloc orthosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10-meter walk test (in seconds)
Time Frame: comparison between baseline and 15 days
|
Maximum gait velocity, from a standing start
|
comparison between baseline and 15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
comparison between baseline and 15 days
|
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
|
comparison between baseline and 15 days
|
Baropodometric analysis during gait
Time Frame: comparison between baseline and 15 days
|
Assessment of the paretic footprint during gait, using the Zebris platform
|
comparison between baseline and 15 days
|
Gait endurance (2-minute walk test)
Time Frame: comparison between baseline and 15 days
|
Assessment of maximum gait perimeter during a 2mwt
|
comparison between baseline and 15 days
|
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
|
comparison between baseline and 15 days
|
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)
|
at 15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2019
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
August 1, 2018
First Submitted That Met QC Criteria
September 11, 2018
First Posted (Actual)
September 12, 2018
Study Record Updates
Last Update Posted (Actual)
November 4, 2022
Last Update Submitted That Met QC Criteria
November 3, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017_01
- 2017-A02098-45 (Other Identifier: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemiparesis
-
University of MinnesotaCompleted
-
Pamukkale UniversityCompletedSatisfaction, Patient | Hemiparesis;Poststroke/CVATurkey
-
Pavlos KitixisCompletedHemiplegia and HemiparesisGreece
-
UGECAM Rhône-AlpesRecruitingHemiparesis;Poststroke/CVAFrance
-
Loma Linda UniversityRecruitingHemiparesis;Poststroke/CVAUnited States
-
Reuth Rehabilitation HospitalUniversity of HaifaRecruitingHemiparesis;Poststroke/CVAIsrael
-
Taipei Medical University WanFang HospitalWithdrawnPoststroke/CVA HemiparesisTaiwan
-
NYU Langone HealthCompleted
-
University of MinnesotaCompletedCongenital HemiparesisUnited States
-
University of IdahoUniversity of California, IrvineNot yet recruitingHemiparesis; Poststroke/CVA