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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00284115
Recruitment Status : Terminated
First Posted : January 31, 2006
Last Update Posted : July 4, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Hemiplegia Stroke Device: Gait trainer Device: Conventional rehabilitation

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of a Mechanical Gait Repetitive Training Technique Compared With a Usual Rehabilitation Program on Gait Recovery in Hemiparetic Stroke Patients
Study Start Date : March 2006
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program [ Time Frame: after 4 weeks ]

Secondary Outcome Measures :
  1. Functional ambulatory category [ Time Frame: Days 0, 15, 28 and 90. ]
  2. Walking endurance (6 minute walk) [ Time Frame: days 15, 28 and 90. ]
    distance covered in a 6 minutes confortable walk

  3. Time to self sufficient gait recovery [ Time Frame: Since inclusion Time ]
  4. Spasticity (modified Ashworth score) [ Time Frame: Days 0, 15, 28 and 90 ]
  5. Motricity index [ Time Frame: Days 0, 15, 28 and 90 ]
  6. Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance) [ Time Frame: Days 0, 15, 28 and 90 ]
  7. Economic evaluation (healthcare requirements, rehabilitation unit length of stay) [ Time Frame: At the end of the study ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284115


Locations
France
Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger
Aulnay sous Bois, France, 93602
Centre du Docteur Bouffart-Vercelli
Cerbère, France, 66290
Centre de Rééducation de Coubert
Coubert, France, 77170
Rééducation Fonctionnelle - Hôpital Raymond Poincaré
Garches, France, 92380
Centre l'espoir
Hellemmes, France, 59260
Centre Bretegnier
Héricourt, France, 70400
Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol
Limoges, France, 87000
Service de Médecine Physique et Réadaptation - Hôpital de l'Archet
Nice, France, 06202
Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi
Nîmes, France, 30029
Service de Rééducation Neuro-orthopédique - Hôpital Rothschild
Paris, France, 75012
Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
Rennes, France, 35033
Centre de l'Arche
Saint Saturnin, France, 72650
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Principal Investigator: Régine Brissot, MD CHU Rennes
Study Chair: Bruno Laviolle, MD CHU Rennes
More Information

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00284115     History of Changes
Other Study ID Numbers: AFSSAPS 2005/10/006
PHRC/04-02 ( Other Identifier: Rennes University Hospital )
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: July 2012

Keywords provided by Rennes University Hospital:
Gait trainer
Hemiplegia
Rehabilitation
Stroke

Additional relevant MeSH terms:
Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms