Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke

Not Applicable

Terminated

Conditions: Stroke

Interventions: Device: Robotic Therapy
Device: Active tDCS
Device: Sham tDCS
Other: Physical Therapy
Other: Occupational Therapy

Registration Number: NCT02416791

Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary: Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. This study addresses this important issue, by combining two different interventions in the early phase post-stroke: robotic therapy associated or not with transcranial direct current stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor upper limb rehabilitation.

Detailed Description: Our main goal is to confirm the safety of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy, and to conventional therapy alone, for upper limb rehabilitation in an early phase (3-9 weeks) after stroke. Patients will be randomized to receive one of these three treatments, 3 times per week, for 6 weeks.

Data about eventual adverse effect will be collected in each session of treatment. The working hypothesis is that robotic therapy associated with active tDCS and conventional therapy will be as safe as robotic therapy associated with conventional therapy, and as conventional therapy alone.

We will aso preliminarily evaluate the efficacy of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy alone, in improvement of upper limb motor impairment.

Our secondary goals are: 1) To evaluate safety and upper limb motor impairments in patients submitted to each of the three interventions, 6 months after end of treatment; 2) To compare effects of the abovementioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke, immediately after treatment and 6 months later.

The working hypothesis is that the association of robotic therapy, tDCS and conventional therapy will lead to better outcomes than robotic therapy and conventional therapy, or conventional therapy alone.

Patients will be assessed before the first session and after the last session of treatment, as well as 6 months after the last session of treatment.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 9

Inclusion Criteria

Ischemic or hemorrhagic stroke onset 3 - 9 weeks before the recruiting, confirmed by computed tomography or magnetic resonance imaging.
Moderate to severe motor impairment of an upper limb, defined as a score between 7 - 42 on the Upper Limb Subscale of Fugl Meyer Assessment of Sensorimotor Recovery after stroke.
Ability to provide written informed consent (patient ou legal representative)
Ability to comply with the schedule of interventions and evaluations in the protocol.

Exclusion Criteria

Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of > 3 on the Modified Ashworth Spasticity Scale.
Upper limb plegia
Uncontrolled medical problems such as end-stage cancer or renal disease
Pregnancy
Seizures, except for a single seizure during the first week post stroke
Pacemakers
Other neurological disorders such as Parkinson's disease
Psychiatric illness including severe depression
Aphasia ou severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
Hemineglect
Drugs that interfere on cortical excitability, except for antidepressants
Cerebellar lesions

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS + robotic therapy + physical therapy	Active tDCS	Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Active tDCS + robotic therapy + physical therapy	Physical Therapy	Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks).
sham tDCS + physical therapy + occupational therapy	Physical Therapy	Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
sham tDCS + robotic therapy + physical therapy	Robotic Therapy	Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks).
sham tDCS + robotic therapy + physical therapy	Sham tDCS	Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks).
sham tDCS + physical therapy + occupational therapy	Occupational Therapy	Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Active tDCS + robotic therapy + physical therapy	Robotic Therapy	Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks).
sham tDCS + robotic therapy + physical therapy	Physical Therapy	Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks).
sham tDCS + physical therapy + occupational therapy	Sham tDCS	Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).

Primary Outcome Measures

Name	Time	Method
Percentage of Sessions With Adverse Events	Post treatment (6 weeks from baseline).
Change in Upper Extremity Fugl Meyer Assessment	6 weeks from baseline	Change in Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.

Secondary Outcome Measures

Name	Time	Method
Change in National Institutes of Health Stroke Scale	6 weeks from baseline	Scores range from 0 to 42. Higher scores indicate greater severity.
Upper Extremity Fugl Meyer Assessment	6 months follow-up	Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.
Change in Fatigue Severity Scale	6 weeks from baseline	Fatigue Severity Scale is a 9 -item questionnaire. Each item scores on a 7-point scale. The total score range from 9 to 63 points. Higher scores indicate greater fatigue.
Number of Participants Who Presented Score on Modified Ashworth Scale >2	6 weeks	Scores range from 0 to 4, with 5 choices. A score of 1 indicates no resistance, and 4 indicates rigidity.
Number of Participants With Adverse Events	6 months follow-up
Change in Stroke Impact Scale	6 weeks from baseline	Scores in each domain of the Stroke Impact Scale range from 0 to 100, with higher scores indicating a better quality of life. The change was calculated as the value at the later time point minus the value at the earlier time point; so that, positive numbers represent increases and negative numbers represent decreases.
Change in Pittsburgh Sleep Quality Index	6 weeks from baseline	The global Pittsburgh Sleep Quality Index score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21. Lower scores denote a healthier sleep quality.
Change in Modified Rankin Scale	6 weeks from baseline	Scores range from 0 to 6. Higher scores indicate greater severity.
Change in Motor Activity Log	6 weeks from baseline	Each domain contains taks scored on 0 to 5 ordinal scale. Lower scores indicate greater severity.