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

Rennes University Hospital122 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Hemiplegia Stroke

Interventions

Gait trainerDEVICE

Mechanical gait repetitive training

Conventional rehabilitationDEVICE

Physiotherapeutic conventional rehabilitation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger

Aulnay-sous-Bois, France

Centre du Docteur Bouffart-Vercelli

Cervera de la Marenda, France

Centre de Rééducation de Coubert

Coubert, France

Outcomes

Primary Outcomes

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

Time frame: after 4 weeks

Secondary Outcomes

Functional ambulatory category

Time frame: Days 0, 15, 28 and 90.

Walking endurance (6 minute walk)

distance covered in a 6 minutes confortable walk

Time frame: days 15, 28 and 90.

Time to self sufficient gait recovery

Time frame: Since inclusion Time

Spasticity (modified Ashworth score)

Time frame: Days 0, 15, 28 and 90

Motricity index

Time frame: Days 0, 15, 28 and 90

Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)

Time frame: Days 0, 15, 28 and 90

Economic evaluation (healthcare requirements, rehabilitation unit length of stay)

Time frame: At the end of the study

Data from ClinicalTrials.gov

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