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

Not Applicable

Terminated

• Conditions: Hemiplegia; Stroke
• Interventions: Device: Gait trainer; Device: Conventional rehabilitation

• Registration Number: NCT00284115
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2006-01-30
• Study First Submitted QC: 2006-01-30
• Study First Posted: 2006-01-31
• Study Start: 2006-03
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-03
• Last Update Posted: 2012-07-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical gait repetitive training	Gait trainer	Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement
Conventional rehabilitation program	Conventional rehabilitation	Physiotherapeutic conventional rehabilitation program

Primary Outcome Measures

Name	Time	Method
Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program	after 4 weeks

Secondary Outcome Measures

Name	Time	Method
Functional ambulatory category	Days 0, 15, 28 and 90.
Time to self sufficient gait recovery	Since inclusion Time
Spasticity (modified Ashworth score)	Days 0, 15, 28 and 90
Economic evaluation (healthcare requirements, rehabilitation unit length of stay)	At the end of the study
Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)	Days 0, 15, 28 and 90
Walking endurance (6 minute walk)	days 15, 28 and 90.	distance covered in a 6 minutes confortable walk
Motricity index	Days 0, 15, 28 and 90

Trial Locations

Locations (12)

Centre de Rééducation de Coubert; 🇫🇷 Coubert, France

Centre du Docteur Bouffart-Vercelli; 🇫🇷 Cerbère, France

Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi; 🇫🇷 Nîmes, France

Service de Rééducation Neuro-orthopédique - Hôpital Rothschild; 🇫🇷 Paris, France

Rééducation Fonctionnelle - Hôpital Raymond Poincaré; 🇫🇷 Garches, France

Centre l'espoir; 🇫🇷 Hellemmes, France

Centre Bretegnier; 🇫🇷 Héricourt, France

Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol; 🇫🇷 Limoges, France

Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger; 🇫🇷 Aulnay sous Bois, France

Service de Médecine Physique et Réadaptation - Hôpital de l'Archet; 🇫🇷 Nice, France

Centre de l'Arche; 🇫🇷 Saint Saturnin, France

Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou; 🇫🇷 Rennes, France