Efficacy of a Mechanical Gait Repetitive Training Technique in Hemiparetic Stroke Patients (AVC)
This study has been terminated.
Sponsor:
Rennes University Hospital
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
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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
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:
|
Hemiplegia Stroke Cerebral Infarction Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 16, 2013