Robotic Versus Conventional Training on Hemiplegic Gait.

Study Overview
=================
Brief Summary
-----------------
The incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. In the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. But so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions after stroke.

Official Title
-----------------
A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: conventional therapy
* Device: conventional plus robotic gait assisted therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subacute first-time stroke patients(hemorrhage and ischemic) Age 18-80 years. Impaired Functional Ambulation Category at initial score 0-2 Cardiovascular stable Given signed inform consent Exclusion Criteria: Unstable general medical condition Severe malposition or fixed contracture of joint with an extension deficit of more than 30 degree Any functional impairment prior to stroke Can not adequately cooperate in training Severe communication problems Severe cognitive - perceptual deficits

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group A = conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks | Behavioral: conventional therapy<br>* conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks<br>|
| Active Comparator: Group B<br>Group B = conventional therapy plus robot-assisted means: 30 min individual physiotherapy plus 20 min robot-assisted gait training and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks | Device: conventional plus robotic gait assisted therapy<br>* individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy<br>* Other names: Gait trainer GT1;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ambulation Categories (FAC, 0-5) | Description of ambulation level of the individual patient, whether and if, how much support is needed. | 4 weeks | 
| Barthel index (BI, 0-100) | Assesses independence in activity of daily living | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale (BBS, 0-56 | Assesses balance abilities. | 4 weeks | 
| REPAS -Muscle tone (REPAS, 0-52) | Sum score to assess muscle tone for the major joints of the upper and lower extremities. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, rehabilitation, gait training, robot-assisted therapy