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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of a Mechanical Gait Repetitive Training Technique Compared With a Usual Rehabilitation Program on Gait Recovery in Hemiparetic Stroke Patients

Conditions
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Hemiplegia, Stroke

Intervention / Treatment
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* Device: Gait trainer
* Device: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical gait repetitive training<br>Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement | Device: Gait trainer<br>* Mechanical gait repetitive training<br>|
| Active Comparator: Conventional rehabilitation program<br>Physiotherapeutic conventional rehabilitation program | Device: Conventional rehabilitation<br>* Physiotherapeutic conventional rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program |  | after 4 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait trainer, Hemiplegia, Rehabilitation, Stroke