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

Rennes University Hospital

Status: Terminated

Conditions: Stroke; Hemiplegia

Treatments: Device: Gait trainer; Device: Conventional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT00284115

AFSSAPS 2005/10/006

PHRC/04-02 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Mechanical gait repetitive training

Experimental group

Description:

Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement

Treatment:

Device: Gait trainer

Conventional rehabilitation program

Active Comparator group

Description:

Physiotherapeutic conventional rehabilitation program

Treatment:

Device: Conventional rehabilitation