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Efficacy of a Mechanical Gait Repetitive Training Technique in Hemiparetic Stroke Patients (AVC)

NCT ID: NCT00284115

Last Updated: 2012-07-04

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

TERMINATED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2011-05-31

Brief Summary

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Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.

Detailed Description

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Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. The aim of the study is to test the efficacy of a body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gait-like movement compared to a conventional rehabilitation program in the acute phase. Hemiparetic stroke patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone.

The primary endpoint will be the walking speed (time needed to walk 10 m) at the end of the rehabilitation program. Functional ambulatory category, walking endurance, time to self sufficient gait recovery, needing for mobility and self assistance, spasticity and economic evaluation of the two strategies will also be assessed.

Conditions

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Hemiplegia Stroke

Keywords

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Gait trainer Hemiplegia Rehabilitation Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mechanical gait repetitive training

Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement

Group Type EXPERIMENTAL

Gait trainer

Intervention Type DEVICE

Mechanical gait repetitive training

Conventional rehabilitation program

Physiotherapeutic conventional rehabilitation program

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type DEVICE

Physiotherapeutic conventional rehabilitation

Interventions

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Gait trainer

Mechanical gait repetitive training

Intervention Type DEVICE

Conventional rehabilitation

Physiotherapeutic conventional rehabilitation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men or women aged 18 years or more
* Hemiplegia secondary to stroke
* Interval between stroke and study inclusion of 4 month or less
* First supratentorial stroke or no motor sequelae in case of history of transient ischemic stroke
* Non ambulatory patient (Functional Ambulatory Category Stage 0 or 1)
* Being able to sit unsupported at the edge of the bed
* No severe impairment of cognition or communication
* Written informed consent

Exclusion Criteria

* Orthopedic and/or rheumatological disease impairing mobility
* Other Neurological associated disease
* History of myocardial infarction or deep venous embolism or pulmonary embolism less than 3 months before study inclusion
* Chronic pulmonary disease
* Intolerance to stand up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Régine Brissot, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Bruno Laviolle, MD

Role: STUDY_CHAIR

CHU Rennes

Locations

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Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger

Aulnay-sous-Bois, , France

Site Status

Centre du Docteur Bouffart-Vercelli

Cervera de la Marenda, , France

Site Status

Centre de Rééducation de Coubert

Coubert, , France

Site Status

Rééducation Fonctionnelle - Hôpital Raymond Poincaré

Garches, , France

Site Status

Centre l'espoir

Hellemmes-Lille, , France

Site Status

Centre Bretegnier

Héricourt, , France

Site Status

Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol

Limoges, , France

Site Status

Service de Médecine Physique et Réadaptation - Hôpital de l'Archet

Nice, , France

Site Status

Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi

Nîmes, , France

Site Status

Service de Rééducation Neuro-orthopédique - Hôpital Rothschild

Paris, , France

Site Status

Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou

Rennes, , France

Site Status

Centre de l'Arche

Saint-Saturnin, , France

Site Status

Countries

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France

Other Identifiers

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PHRC/04-02

Identifier Type: OTHER

Identifier Source: secondary_id

AFSSAPS 2005/10/006

Identifier Type: -

Identifier Source: org_study_id