Efficacy of TOCT and (tDCS) for Gait Improvement in Patients With Chronic Stroke
NCT ID: NCT01883843
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2013-05-31
2014-09-30
Brief Summary
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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
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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real tDCS + TOCT
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.
real tDCS + TOCT
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.
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.
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.
Interventions
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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.
real tDCS + TOCT
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of first ischemic stroke \> 6 months.
* MMSE\>24;
* FAC higher or equal to 4
Exclusion Criteria
* Neurological or psychiatric pathology.
* Severe cardio-pulmonary, renal, hepatic diseases.
* Pregnancy.
18 Years
75 Years
ALL
Yes
Sponsors
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University Hospital of Ferrara
OTHER
Responsible Party
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Sofia Straudi, MD
Physical Medicine and Rehabilitation doctor
Principal Investigators
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Sofia Straudi, MD
Role: PRINCIPAL_INVESTIGATOR
Ferrara Rehabilitation Hospital
Locations
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Ferrara University Hospital
Ferrara, Ferrara, Italy
Countries
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References
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Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Other Identifiers
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Stroke_tDCS_TOCT
Identifier Type: -
Identifier Source: org_study_id