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

This study is currently recruiting participants.
Verified January 2014 by University Hospital of Ferrara
Sponsor:
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier:
NCT01883843
First received: June 14, 2013
Last updated: January 15, 2014
Last verified: January 2014

June 14, 2013
January 15, 2014
May 2013
October 2013   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01883843 on ClinicalTrials.gov Archive Site
  • 10 meter walking test (test of 10m) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up ] [ Designated as safety issue: No ]
    walking speed test
  • 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. ] [ Designated as safety issue: No ]
  • Unified Balance Scale (UBS) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. ] [ Designated as safety issue: No ]
  • Fatigue Severity Scale (FSS) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of TOCT and (tDCS) for Gait Improvement in Patients With Chronic Stroke
Efficacy of a Task-oriented Circuit Training Associated With Transcranial Direct Current Stimulation (tDCS) for Gait Improvement in Chronic Stroke Patients . A Randomized Controlled Trial

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:

  • 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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Stroke
  • Device: sham tDCS + TOCT
  • Device: real tDCS + TOCT
  • Experimental: 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.

    Intervention: Device: real tDCS + TOCT
  • Active Comparator: 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.
    Intervention: Device: sham tDCS + TOCT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
October 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Males and females subjects. Age > 18 years, <75 years.
  • Diagnosis of first ischemic stroke > 6 months.
  • MMSE>24;
  • FAC higher or equal to 4

Exclusion Criteria:

  • Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current, presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants).
  • Neurological or psychiatric pathology.
  • Severe cardio-pulmonary, renal, hepatic diseases.
  • Pregnancy.
Both
18 Years to 75 Years
Yes
Contact: Carlotta Martinuzzi, PT 0039 0532 238720 costes@alice.it
Italy
 
NCT01883843
Stroke_tDCS_TOCT
Yes
Sofia Straudi, MD, University Hospital of Ferrara
University Hospital of Ferrara
Not Provided
Not Provided
University Hospital of Ferrara
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP