Efficacy of TOCT and (tDCS) for Gait Improvement in Patients With Chronic Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      Stroke is one of the major causes of disability in the Western world. Initially gait is the
      most affected function, 80% of patients lose this ability.

      Rehabilitation in stroke patients improves walking abilities in terms of gait and related
      gait activities, though six months after stroke many patients are significantly disabled.

      Recently, a prospective study of 205 stroke patients showed that approximately 21% of
      patients have a significant decrease of mobility between the first and the third year after
      stroke. The main finding showed that inactivity was the most important factor for the
      mobility decline.

      Evidence about effects of direct current brain stimulation on motor recovery function of
      lower limb are still little, some show that quadriceps strength after stimulation of damaged
      M1 area increased. Another study where tDCS was associated with robotic gait training did not
      report any effect compared to treatment alone. It is necessary to define if a different
      dosage of stimulation or the association of tDCS with gait training can improve walking and
      if further studies are required to investigate their effectiveness.

      The aim of this clinical trial is to test the possibility of gait improvement through the
      association of tDCS with a specific task-oriented circuit training for walking abilities,
      balance and mobility.
    

Detailed description: 
      Inclusion criteria:

        -  Males and females subjects. Age > 18 years, <75 years.

        -  Diagnosis of first ischemic stroke > 6 months.

        -  Mini mental State Examination (MMSE) >24;

        -  Functional Ambulation Classification (FAC) higher or equal to 4
    

Intervention name(s): sham tDCS + TOCT; real tDCS + TOCT
Intervention type(s): Device; Device
Intervention description(s): Every day will be given a continuous low-intensity stimulation of 0.5mA (for a current density of 60μA/cm2) only for 10 seconds at the beginning and at the end of the stimulation for 10 consecutive days after any rehabilitative treatment. The mounting of electrodes for sham stimulation is the same used for the experimental group.; Every day will be given continuous stimulation duration of 15 minutes with intensity of 0.5 mA (for a current density of 60μA/cm2), generated by a constant current stimulator rechargeable batteries for 10 consecutive days after any rehabilitation treatment in the gym. Two sponge electrodes are placed, soaked in saline solution, fixed by an elastic band, the anode consists of an electrode oblong 8cm2 positioned at M1 area on the lower limb affection (following the medial sagittal axis, with the center of the electrode positioned at one centimeter laterally to the vertex) while the cathode (48cm2) is placed in the contralateral supraorbitale area as reference electrode. The current reaches 0.5mA and decreases with a ramp of 10 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Stroke; tDCS; transcranial direct current stimulation; task oriented circuit training; TOCT; gait training