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

July 3, 2012 updated by: Rennes University Hospital

Efficacy of a Mechanical Gait Repetitive Training Technique Compared With a Usual Rehabilitation Program on Gait Recovery in Hemiparetic Stroke Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

122

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 Locations

  • France
      • Aulnay sous Bois, France, 93602
        • Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger
      • Cerbère, France, 66290
        • Centre du Docteur Bouffart-Vercelli
      • Coubert, France, 77170
        • Centre de Rééducation de Coubert
      • Garches, France, 92380
        • Rééducation Fonctionnelle - Hôpital Raymond Poincaré
      • Hellemmes, France, 59260
        • Centre l'espoir
      • Héricourt, France, 70400
        • Centre Bretegnier
      • Limoges, France, 87000
        • Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol
      • Nice, France, 06202
        • Service de Médecine Physique et Réadaptation - Hôpital de l'Archet
      • Nîmes, France, 30029
        • Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi
      • Paris, France, 75012
        • Service de Rééducation Neuro-orthopédique - Hôpital Rothschild
      • Rennes, France, 35033
        • Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
      • Saint Saturnin, France, 72650
        • Centre de l'Arche

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mechanical gait repetitive training
Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement
Device: Gait trainer
Mechanical gait repetitive training
Active Comparator: Conventional rehabilitation program
Physiotherapeutic conventional rehabilitation program
Device: Conventional rehabilitation
Physiotherapeutic conventional rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program
Time Frame: after 4 weeks
after 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional ambulatory category
Time Frame: Days 0, 15, 28 and 90.
Days 0, 15, 28 and 90.
Walking endurance (6 minute walk)
Time Frame: days 15, 28 and 90.
distance covered in a 6 minutes confortable walk
days 15, 28 and 90.
Time to self sufficient gait recovery
Time Frame: Since inclusion Time
Since inclusion Time
Spasticity (modified Ashworth score)
Time Frame: Days 0, 15, 28 and 90
Days 0, 15, 28 and 90
Motricity index
Time Frame: Days 0, 15, 28 and 90
Days 0, 15, 28 and 90
Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)
Time Frame: Days 0, 15, 28 and 90
Days 0, 15, 28 and 90
Economic evaluation (healthcare requirements, rehabilitation unit length of stay)
Time Frame: At the end of the study
At the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Régine Brissot, MD, CHU Rennes

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

March 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

January 30, 2006

First Submitted That Met QC Criteria

January 30, 2006

First Posted (Estimate)

January 31, 2006

Study Record Updates

Last Update Posted (Estimate)

July 4, 2012

Last Update Submitted That Met QC Criteria

July 3, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFSSAPS 2005/10/006
  • PHRC/04-02 (Other Identifier: Rennes University Hospital)

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.

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