A Phase 2 interventional study of sham tDCS + TOCT and real tDCS + TOCT in Stroke, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-23.
Sponsored by University Hospital of Ferrara · Phase 2, Interventional, and Treatment
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.
Inclusion criteria:
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 21 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital of Ferrara is the lead sponsor of 110 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: real tDCS + TOCT
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.
Device: sham tDCS + TOCT
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.
Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.
10 meter walking test (test of 10m)
walking speed test
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up
Timed "up and go" test (TUG)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Unified Balance Scale (UBS)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Fatigue Severity Scale (FSS)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Stroke Impact Scale (SIS) version 3.0
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Stroke Specific Quality of Life (SS-QOL)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University Hospital of Ferrara