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

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT01883843
• Study type: Interventional
• Source: University Hospital of Ferrara
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Completion date: September 2014