Mechanized Gait Trainer Combine Transcranial Galvanic Stimulation (tDCS) in Chronic Stroke
NCT ID: NCT01040299
Last Updated: 2012-03-26
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2010-07-31
2010-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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GangTrainer and tDCS
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.
GangTrainer and tDCS
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.
control group1
The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
control group1
The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
control group2
The control group 2 receive a total of 10 treatments with convectional physiotherapy.
Control group2
The control group 2 receive a total of 10 treatments with convectional physiotherapy.
Interventions
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GangTrainer and tDCS
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.
control group1
The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
Control group2
The control group 2 receive a total of 10 treatments with convectional physiotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
80 Years
ALL
No
Sponsors
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Universita di Verona
OTHER
Responsible Party
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Nicola Smania, MD
professor
Principal Investigators
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Nicola Smania Nicola Smania, Doctor
Role: PRINCIPAL_INVESTIGATOR
Locations
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Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
Verona, Italy, Verona, Italy
Countries
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References
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Hesse S, Werner C, Schonhardt EM, Bardeleben A, Jenrich W, Kirker SG. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: a pilot study. Restor Neurol Neurosci. 2007;25(1):9-15.
Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.
Dias D, Lains J, Pereira A, Nunes R, Caldas J, Amaral C, Pires S, Costa A, Alves P, Moreira M, Garrido N, Loureiro L. Can we improve gait skills in chronic hemiplegics? A randomised control trial with gait trainer. Eura Medicophys. 2007 Dec;43(4):499-504.
Other Identifiers
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GT-1-tDCS
Identifier Type: -
Identifier Source: org_study_id
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