Clinical trial NCT01040299: Mechanized Gait Trainer Combine Transcranial Galvanic Stimulation (tDCS) in Chronic Stroke
Official title: Combine Mechanized Gait Trainer and Transcranial Direct Current Stimulation in Chronic Stroke Patients: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Cerebrovascular Disorders
Keywords: GangTrainer
Gait Rehabilitation
Cerebrovascular Disorders
Robot assisted
Transcranial direct current stimulation
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2009-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Motricity Index
timeFrame: 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 outcomes:
measure: Barthel Index
timeFrame: 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
measure: European Stroke Scale
timeFrame: 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
measure: Modified Ashworth Scale
timeFrame: 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
measure: Questionary of Ambulation
timeFrame: 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
measure: Rivermead Motor Assessment Score
timeFrame: 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
measure: Functional Ambulation Category
timeFrame: 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
measure: Ten Meters Walking Test
timeFrame: 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
measure: Six Minutes Walking Test
timeFrame: 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
measure: Spatia-temporal Gait analysis
timeFrame: 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
measure: Motricity Index
timeFrame: 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
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
state: Italy, Verona
Study officials:
name: Nicola Smania Nicola Smania, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.