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

NCT03668561 | Terminated

• 2 other identifiers: 2017_012017-A02098-45
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemiparesis; Varus Deformity of Equine Carpus

Keywords

stroke; hemiplegia

Outcome Measures

Primary Outcomes (1)

• 10-meter walk test (in seconds)

  Maximum gait velocity, from a standing start

  comparison between baseline and 15 days

Secondary Outcomes (6)

• Assessment of gait temporospatial parameters by GaitRite®

  comparison between baseline and 15 days

• Posturographic analysis during static upright stance (center of pressure surface)

  comparison between baseline and 15 days

• Baropodometric analysis during gait

  comparison between baseline and 15 days

• Gait endurance (2-minute walk test)

  comparison between baseline and 15 days

• Assessment of walking function

  comparison between baseline and 15 days

Study Arms (1)

Treatment (CALIGALOC)

EXPERIMENTAL

Wearing of the Caligaloc orthosis

Device: Caligaloc

Interventions

Caligaloc DEVICE

15 days of wearing of the Caligaloc orthosis

Treatment (CALIGALOC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unable to walk 10m
• history of neurological or locomotor pathology in addition to the etiology of hemiparesis
• Severe comprehension troubles
• Pregnancy

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Swynghedau, CHI

Lille, France

Location

MeSH Terms

Conditions

Paresis; Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis

Study Officials

• Etienne Allart, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: September 12, 2018
• Study Start: February 22, 2019
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

FR (1)