Clinical trial NCT01883843: Efficacy of TOCT and (tDCS) for Gait Improvement in Patients With Chronic Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Chronic Stroke
tDCS
transcranial direct current stimulation
task oriented circuit training
TOCT
gait training
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT)
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.
Secondary outcomes:
measure: 10 meter walking test (test of 10m)
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up
measure: Timed "up and go" test (TUG)
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
measure: Unified Balance Scale (UBS)
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
measure: Fatigue Severity Scale (FSS)
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
measure: Stroke Impact Scale (SIS) version 3.0
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
measure: Stroke Specific Quality of Life (SS-QOL)
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
affiliation: Ferrara Rehabilitation Hospital
name: Sofia Straudi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.