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

Completed

Phase N/A Results N/A

Trial 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, 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

Conditions

Interventions

  • GangTrainer and tDCS Device
    Other Names: GangTrainer and tDCS
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: GangTrainer and tDCS
    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.
  • Control group1 Device
    Other Names: GangTrainerGT1
    Intervention Desc: The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
    ARM 1: Kind: Experimental
    Label: control group1
    Description: The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
  • Control group2 Other
    Other Names: convectional physiotherapy
    Intervention Desc: The control group 2 receive a total of 10 treatments with convectional physiotherapy.
    ARM 1: Kind: Experimental
    Label: control group2
    Description: The control group 2 receive a total of 10 treatments with convectional physiotherapy.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Motricity Index Baseline, Post-Treatment and 1 month Follow-up Yes
Secondary Barthel Index Baseline, Post-Treatment and 1 month Follow-up Yes
Secondary European Stroke Scale Baseline, Post-Treatment and 1 month Follow-up Yes
Secondary Modified Ashworth Scale Baseline, Post-Treatment and 1 month Follow-up Yes
Secondary Questionary of Ambulation Baseline, Post-Treatment and 1 month Follow-up Yes
Secondary Rivermead Motor Assessment Score Baseline, Post-Treatment and 1 month Follow-up Yes
Secondary Functional Ambulation Category Baseline, Post-Treatment and 1 month Follow-up Yes
Secondary Ten Meters Walking Test Baseline, Post-Treatment and 1 month Follow-up Yes
Secondary Six Minutes Walking Test Baseline, Post-Treatment and 1 month Follow-up Yes
Secondary Spatia-temporal Gait analysis Baseline, Post-Treatment and 1 month Follow-up Yes

Sponsors