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

December 19, 2014 updated by: Sofia Straudi, MD, University Hospital of Ferrara

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy, 44124
        • Ferrara University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
walking speed test
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.
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.
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.
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.
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.
1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 19, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stroke_tDCS_TOCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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