Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Percentage of Sessions With Adverse Events
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Percentage of Sessions With Adverse Events
Time Frame: Post treatment (6 weeks from baseline).
Change in Upper Extremity Fugl Meyer Assessment
Time Frame: 6 weeks from baseline
Change in Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.
Secondary Outcomes
- Change in National Institutes of Health Stroke Scale(6 weeks from baseline)
- Upper Extremity Fugl Meyer Assessment(6 months follow-up)
- Change in Fatigue Severity Scale(6 weeks from baseline)
- Number of Participants Who Presented Score on Modified Ashworth Scale >2(6 weeks)
- Number of Participants With Adverse Events(6 months follow-up)
- Change in Stroke Impact Scale(6 weeks from baseline)
- Change in Pittsburgh Sleep Quality Index(6 weeks from baseline)
- Change in Modified Rankin Scale(6 weeks from baseline)
- Change in Motor Activity Log(6 weeks from baseline)