Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke "ROTS"

Terminated

Phase N/A Results N/A

Update History

19 May '17
The gender criteria for eligibility was updated to "All."
A location was updated in São Paulo.
New
The overall status was removed for Hospital das Clínicas.
25 Dec '15
The Summary of Purpose was updated.
New
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.
Old
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.
The description was updated.
New
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.
Old
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.
The eligibility criteria were updated.
New
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
Old
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 - 38 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 - 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. A score in the Mini Mental State Examination lower than 23/30 points will be used with patients with higher than 1 year of education, and a score under than 19/30 will be used with patients with 1 year of education or less - Hemineglect