Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke

Recruiting

Phase N/A Results N/A

Trial Description

The objective of the study is to evaluate the effectiveness of transcranial direct current stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal stimulation on the impaired hemisphere will be used associated with a robotic treatment.

Detailed Description

As for transcranial direct current stimulation a HDC kit (ATES/EB NEURO, Firenze, Italy) will be used as device. It is a new device generation of stimulator able to provide an effective stimulation pattern.
As robotic device the InMotion wrist robot (Interactive Motion Technologies Inc., Watertown, MA, USA) will be used. It is an end-effector robotic device able to assist as needed the wrist movements.

Conditions

Interventions

  • TDCS plus wrist robot therapy Device
    Intervention Desc: Patients receive robotic rehabilitation session while tDCS stimulator is switched on
    ARM 1: Kind: Experimental
    Label: tDCS plus wrist robot therapy
    Description: In addition to standard rehabilitation treatment Group A will perform daily sessions of wrist robot-assisted treatment in combination with tDCS (30 minutes). During first 20 min of each session the patient receives a direct current stimulation through surface sponge electrodes (35 cm2), 2 milliampere intensity: the anodal electrode is placed on presumed lesional area, the cathodal electrode is placed on the controlateral orbital bone.
  • Sham tDCS plus wrist robot therapy Device
    Intervention Desc: Patients receive robotic rehabilitation session while tDCS stimulator is switched off.
    ARM 1: Kind: Experimental
    Label: Sham tDCS plus wrist robot therapy
    Description: Group B is treated as Group A, but tDCS, even if the cap is applied on the patient head, is not activated and no current is delivered.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline in the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) at 6 weeks 6 weeks No
Primary Change from Baseline in the Motricity Index 6 weeks No
Primary Change from Baseline in the Modified Ashworth Scale 6 weeks No
Primary Change from Baseline in the Block and Box test 6 weeks No
Secondary Change from Baseline in the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) at 6 months 6 months No
Secondary Change from Baseline in the Motricity Index at 6 months 6 months No
Secondary Change from Baseline in the Modified Ashworth Scale at 6 months 6 months No
Secondary Change from Baseline in the Block and Box test at 6 months 6 months No
Primary Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) 6 weeks No
Secondary Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index 6 weeks No
Secondary Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale 6 weeks No
Secondary Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test 6 weeks No

Sponsors