Clinical trial NCT00284115: Efficacy of a Mechanical Gait Repetitive Training Technique in Hemiparetic Stroke Patients (AVC)
Official title: Efficacy of a Mechanical Gait Repetitive Training Technique Compared With a Usual Rehabilitation Program on Gait Recovery in Hemiparetic Stroke Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemiplegia
Stroke
Keywords: Gait trainer
Hemiplegia
Rehabilitation
Stroke
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2006-01-31
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program
timeFrame: after 4 weeks
Secondary outcomes:
measure: Functional ambulatory category
timeFrame: Days 0, 15, 28 and 90.
measure: Walking endurance (6 minute walk)
timeFrame: days 15, 28 and 90.
measure: Time to self sufficient gait recovery
timeFrame: Since inclusion Time
measure: Spasticity (modified Ashworth score)
timeFrame: Days 0, 15, 28 and 90
measure: Motricity index
timeFrame: Days 0, 15, 28 and 90
measure: Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)
timeFrame: Days 0, 15, 28 and 90
measure: Economic evaluation (healthcare requirements, rehabilitation unit length of stay)
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Aulnay sous Bois
country: France
facility: Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger
city: Cerbère
country: France
facility: Centre du Docteur Bouffart-Vercelli
city: Coubert
country: France
facility: Centre de Rééducation de Coubert
city: Garches
country: France
facility: Rééducation Fonctionnelle - Hôpital Raymond Poincaré
city: Hellemmes
country: France
facility: Centre l'espoir
city: Héricourt
country: France
facility: Centre Bretegnier
city: Limoges
country: France
facility: Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol
city: Nice
country: France
facility: Service de Médecine Physique et Réadaptation - Hôpital de l'Archet
city: Nîmes
country: France
facility: Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi
city: Paris
country: France
facility: Service de Rééducation Neuro-orthopédique - Hôpital Rothschild
city: Rennes
country: France
facility: Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
city: Saint Saturnin
country: France
facility: Centre de l'Arche
Study officials:
affiliation: CHU Rennes
name: Régine Brissot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Bruno Laviolle, MD
role: STUDY_CHAIR
References: