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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883843
• Other study ID #: Stroke_tDCS_TOCT
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2013
• Last updated: December 19, 2014
• Start date: May 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Ferrara University Hospital	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	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)	walking speed test	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