Efficacy of TOCT and (tDCS) for Gait Improvement in Patients With Chronic Stroke

Completed

Phase 2 Results N/A

Trial Description

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

Conditions

Interventions

  • Sham tDCS + TOCT Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: sham-tDCS + TOCT
    Description: 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.
    ARM 2: Kind: Experimental
    Label: sham tDCS + TOCT
    Description: 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.
  • Real tDCS + TOCT Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: real tDCS + TOCT
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT) 1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up. No
Secondary 10 meter walking test (test of 10m) 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up No
Secondary Timed "up and go" test (TUG) 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. No
Secondary Unified Balance Scale (UBS) 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. No
Secondary Fatigue Severity Scale (FSS) 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. No
Secondary Stroke Impact Scale (SIS) version 3.0 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. No
Secondary Stroke Specific Quality of Life (SS-QOL) 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. No

Sponsors