Mechanized Gait Trainer Combine Transcranial Galvanic Stimulation (tDCS) in Chronic Stroke (GT-1-tDCS)

University of Verona

Status

Completed

Conditions

Hemiparesis

Cerebrovascular Disorders

Treatments

Device: GangTrainer and tDCS

Other: Control group2

Device: control group1

Study type

Interventional

Funder types

Other

Identifiers

NCT01040299

GT-1-tDCS

Details and patient eligibility

About

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.

Full description

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

Enrollment

30 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 3 patient groups

GangTrainer and tDCS

Experimental group

Description:

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.

Treatment:

Device: GangTrainer and tDCS

control group1

Sham Comparator group

Description:

The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.

Treatment:

Device: control group1

control group2

Active Comparator group

Description:

The control group 2 receive a total of 10 treatments with convectional physiotherapy.