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

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00284115
First received: January 30, 2006
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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 Intervention
Hemiplegia
Stroke
Device: Gait trainer
Device: Conventional rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional ambulatory category [ Time Frame: Days 0, 15, 28 and 90. ] [ Designated as safety issue: No ]
  • Walking endurance (6 minute walk) [ Time Frame: days 15, 28 and 90. ] [ Designated as safety issue: No ]
    distance covered in a 6 minutes confortable walk

  • Time to self sufficient gait recovery [ Time Frame: Since inclusion Time ] [ Designated as safety issue: No ]
  • Spasticity (modified Ashworth score) [ Time Frame: Days 0, 15, 28 and 90 ] [ Designated as safety issue: No ]
  • Motricity index [ Time Frame: Days 0, 15, 28 and 90 ] [ Designated as safety issue: No ]
  • Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance) [ Time Frame: Days 0, 15, 28 and 90 ] [ Designated as safety issue: No ]
  • Economic evaluation (healthcare requirements, rehabilitation unit length of stay) [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: March 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00284115     History of Changes
Other Study ID Numbers: AFSSAPS 2005/10/006, PHRC/04-02
Study First Received: January 30, 2006
Last Updated: July 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on November 24, 2014