Mechanized Gait Trainer Combine Transcranial Galvanic Stimulation (tDCS) in Chronic Stroke

Study Overview
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Brief Summary
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Transcranial galvanic stimulation (tDCS), seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe lower limb paresis after stroke, the GangTrainer GT1 (GT) proved to be effective, but nevertheless only a few patients could use their affect lower limb functionally in daily life on deambulation after robot training. Therefore the present study intends to combine both approaches, tDCS + GT, apply at the same time every day for two weeks in order to improve the effectiveness of GangTrainer therapy in the gait rehabilitation.

Detailed Description
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Transcranial galvanic stimulation (tDCS), seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe lower limb paresis after stroke, the GangTrainer GT1 (GT) proved to be effective. Therefore the present study intends to combine both approaches, tDCS + GT, apply at the same time every day for two weeks in order to improve the effectiveness of GangTrainer therapy in the gait rehabilitation. The rehabilitation programme are compose 3 kinds of locomotor training interventions (experimental group, control group 1 and control group 2). During intervention experimental group, patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital. The anodal stimulation is expected to facilitate the activity of the lower limb motor area side directly, while the cathodal stimulation of the non-lesioned hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory inputs. The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation, and the control group 2 receive a total of 10 treatments with convectional physiotherapy

Official Title
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Combine Mechanized Gait Trainer and Transcranial Direct Current Stimulation in Chronic Stroke Patients: Randomized Control Trial

Conditions
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Hemiparesis, Cerebrovascular Disorders

Intervention / Treatment
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* Device: GangTrainer and tDCS
* Device: control group1
* Other: Control group2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: European Stroke scale between 75-85 First time supratentorial, ischaemic or hemorrhagic stroke. Diagnosis of ischemic brain injury or intracerebral hemorrhage by MRI or computed tomography > 6 months after the onset of stroke. Age < 80 years. Ability to stand upright, supported or unsupported, for 1 minute. Patients with ischaemic or haemorrhagic stroke. In-patient participating in a comprehensive rehabilitation programme. patients written informed consent of participation in the study approved by the local ethical committee. absence of cardiac, psychological and orthopedic conditions that might interfere with the result. Exclusion Criteria: Preceding epileptic fits. an EEG suspect of elevated cortical excitability. a sensitive scalp skin. severe cognitive impairment. metallic implants within the brain. previous brain neurosurgery. medications altering the level of cortical excitability medications with a presumed positive or negative effect on brain plasticity.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GangTrainer and tDCS<br>The experimental group patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital. | Device: GangTrainer and tDCS<br>* The experimental group patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital.<br>|
| Sham Comparator: control group1<br>The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation. | Device: control group1<br>* The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.<br>* Other names: GangTrainerGT1;|
| Active Comparator: control group2<br>The control group 2 receive a total of 10 treatments with convectional physiotherapy. | Other: Control group2<br>* The control group 2 receive a total of 10 treatments with convectional physiotherapy.<br>* Other names: convectional physiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motricity Index |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU | 
| European Stroke Scale |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU | 
| Modified Ashworth Scale |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU | 
| Questionary of Ambulation |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU | 
| Rivermead Motor Assessment Score |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU | 
| Functional Ambulation Category |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU | 
| Ten Meters Walking Test |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU | 
| Six Minutes Walking Test |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU | 
| Spatia-temporal Gait analysis |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU | 
| Motricity Index |  | All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GangTrainer, Gait Rehabilitation, Cerebrovascular Disorders, Robot assisted, Transcranial direct current stimulation