Observation of the Gait Cycle in Patients With Hemiplegia in Order to Improve the Triggering of Functional Electrical Stimulation

NCT ID: NCT01257646

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-07-31

Brief Summary

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The main objective of this study is the estimation and comparison of the dephasing between the switch heel and the inertial placed on the paretic foot compared to the events of the gait cycle determined by a Gaitrite system (beginning and end of the swing phase) in conditions without stimulation.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Recent stroke group

These patients have hemiplegia following a stroke within the last 6 months

Group Type EXPERIMENTAL

Gait analysis

Intervention Type OTHER

A Gaitrite system, a goniometer, and EMG are used to record data while the patient walks 10 meters.

Old stroke group

The patients have hemiplegia following a stroke that took place at least a year ago

Group Type ACTIVE_COMPARATOR

Gait analysis

Intervention Type OTHER

A Gaitrite system, a goniometer, and EMG are used to record data while the patient walks 10 meters.

Interventions

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Gait analysis

A Gaitrite system, a goniometer, and EMG are used to record data while the patient walks 10 meters.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patient has had a first ischemic or hemorragic stroke (supratentorial) within the last 6 months for the "recent stroke" group, or more than a year ago for the "old stroke" group
* the patient can walk 10 m without human help, with or without a cane, and a deficit of the foot levator requiring the use of technical assistance to remedy this or involving walking problems
* electrostimulated contraction of the anterior tibialis is possible
* patient has been informed and has signed the consent form

Exclusion Criteria

* cognitive disorder making participation in the study difficult
* fixed plantar flexion, knee extended below 0°
* patient refuses to sign consent
* patient is not covered by a social security system
* patient is under any kind of guardianship
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérôme Froger, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Site Status

Countries

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France

Other Identifiers

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2010-A00534-35

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2009/JF-01

Identifier Type: -

Identifier Source: org_study_id