Efficacy of a Mechanical Gait Repetitive Training Technique in Hemiparetic Stroke Patients - Full Text View

Sponsor:	Rennes University Hospital
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00284115

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

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:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

Functional ambulatory category
Walking endurance (6 minute walk)
Time to self sufficient gait recovery
Spasticity (modified Ashworth score)
Motricity index
Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)
Economic evaluation (healthcare requirements, rehabilitaion unit lenght of stay)

Estimated Enrollment:	122
Study Start Date:	March 2006

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 2 month or less
First time supratentorial stroke
Non ambulatory patient (Functional Ambulatory Category Stage 0)
Being able to sit unsupported at the edge of the bed
No severe impairement 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 veinous 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

Contacts

Contact: Régine Brissot, MD	33-2-9928-4219	regine.brissot@chu-rennes.fr
Contact: Bruno Laviolle, MD	33-2-9928-9481	bruno.laviolle@chu-rennes.fr

Locations

France
Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger	Recruiting
Aulnay sous Bois, France, 93602
Contact: Claire Aymard, MD 33-1-4936-7303 claire.aymard@ch-aulnay.fr
Principal Investigator: Claire Aymard, MD
Centre de Rééducation de Coubert	Recruiting
Coubert, France, 77170
Contact: Thierry Albert, MD 33-1-6442-2085 talbert@ugecamidf.fr
Principal Investigator: Thierry Albert, MD
Sub-Investigator: Philippe Vassel, MD
Sub-Investigator: Francois Rhein, MD
Service de Médecine Physique et Réadaptation - Hôpital Emma Ventura	Not yet recruiting
Fort de France, France, 97200
Contact: Patrick René-Corail, MD patrick.rene-corail@chu-fortdefrance.fr
Principal Investigator: Patrick René-Corail, MD
Sub-Investigator: Alexandre Felez, MD
Sub-Investigator: Pascale Olive, MD
Sub-Investigator: Dominique Deguillard, MD
Rééducation Fonctionnelle - Hôpital Raymond Poincaré	Recruiting
Garches, France, 92380
Contact: Bernard Bussel, MD 33-1-4710-7070 bernard.bussel@rpc.aphp.fr
Principal Investigator: Philippe Azouvi, MD
Sub-Investigator: Elisabeth Lebomin, MD
Sub-Investigator: Alexis Schnitzler, MD
Sub-Investigator: Francois Genet, MD
Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol	Recruiting
Limoges, France, 87000
Contact: Pierre Dudognon, MD 33-5-5505-6516 pierre.dudognon@chu-limoges.fr
Principal Investigator: Pierre Dudognon, MD
Sub-Investigator: Jean-Yves Salle, MD
Sub-Investigator: Jean-Christophe Daviet, MD
Sub-Investigator: Charlotte Verdie, MD
Sub-Investigator: Marguerite Munoz, MD
Service de Médecine Physique et Réadaptation - Hôpital de l'Archet	Not yet recruiting
Nice, France, 06202
Contact: Claude Desnuelle, MD 33-4-9203-5505 desnuelle.c@chu-nice.fr
Principal Investigator: Claude Desnuelle, MD
Sub-Investigator: Manuella Fournier-Mehouas, MD
Sub-Investigator: Charles Benaim, MD
Sub-Investigator: Marie-Hélène Soriani-Lefevre, MD
Sub-Investigator: Cécile Ribiere, MD
Sub-Investigator: Marianne Bruno, MD
Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi	Recruiting
Nîmes, France, 30029
Contact: Jacques Pelissier, MD 33-4-6602-2531 jacques.pelissier@chu-nimes.fr
Principal Investigator: Jacques Pelissier, MD
Service de Rééducation Neuro-orthopédique - Hôpital Rothschild	Recruiting
Paris, France, 75012
Contact: Philippe Thoumie, MD 33-1-4019-3658
Principal Investigator: Philippe Thoumie, MD
Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou	Recruiting
Rennes, France, 35033
Contact: Régine Brissot, MD 33-2-9928-4219 regine.brissot@chu-rennes.fr
Principal Investigator: Régine Brissot, MD
Sub-Investigator: Arnaud Lassale, MD
Centre de l'Arche	Recruiting
Saint Saturnin, France, 72650
Contact: Stéphane Gay, MD 33-2-4351-7273 arche.gay@antivirus.oleane.com
Principal Investigator: Stéphane Gay, MD
Centre Hélio-Marin	Not yet recruiting
Vallauris, France, 06223
Contact: Christiane Abbyad, MD 33-4-9295-3085 cabbyad@ugecampacac.com
Principal Investigator: Christiane Abbyad, MD

Sponsors and Collaborators

Rennes University Hospital

Investigators

Principal Investigator:	Régine Brissot, MD	CHU Rennes
Study Chair:	Bruno Laviolle, MD	CHU Rennes

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00284115 History of Changes
Other Study ID Numbers:	AFSSAPS 2005/10/006, PHRC/04-02, CIC0203/042
Study First Received:	January 30, 2006
Last Updated:	May 7, 2007
Health Authority:	France: Afssaps - French Health Products Safety Agency

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 February 09, 2012