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

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03668561
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21.3
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiparesis; Varus Deformity of Equine Carpus	Device: Caligaloc	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Feb 22, 2019
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 10-meter walk test (in seconds) [comparison between baseline and 15 days]

   Maximum gait velocity, from a standing start

Secondary Outcome Measures

1. Assessment of gait temporospatial parameters by GaitRite® [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) [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 [comparison between baseline and 15 days]

   Assessment of the paretic footprint during gait, using the Zebris platform

4. Gait endurance (2-minute walk test) [comparison between baseline and 15 days]

   Assessment of maximum gait perimeter during a 2mwt

5. Assessment of walking function [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 [at 15 days]

   visual analog scale (0=major discomfort - 10=excellent comfort)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Swynghedau, CHI	Lille		France

Sponsors and Collaborators

• University Hospital, Lille

Investigators

• Principal Investigator: Etienne Allart, MD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT03668561
• Other Study ID Numbers: 2017_01; 2017-A02098-45
• First Posted: Sep 12, 2018
• Last Update Posted: Mar 26, 2020
• Last Verified: Mar 1, 2020

• 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: Paresis

Study Results

No Results Posted as of Mar 26, 2020