Clinical trial NCT02416791: Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
Official title: Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: robotic therapy
transcranial direct current stimulation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2015-04-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Drugs that interfere on cortical excitability, except for antidepressants
* Cerebellar lesions

Primary outcomes:
measure: Change in Upper Extremity Fugl Meyer Assessment
timeFrame: 6 weeks from baseline
measure: Percentage of Sessions With Adverse Events
timeFrame: Post treatment (6 weeks from baseline).
Secondary outcomes:
measure: Change in Modified Rankin Scale
timeFrame: 6 weeks from baseline
measure: Change in National Institutes of Health Stroke Scale
timeFrame: 6 weeks from baseline
measure: Change in Stroke Impact Scale
timeFrame: 6 weeks from baseline
measure: Number of Participants Who Presented Score on Modified Ashworth Scale >2
timeFrame: 6 weeks
measure: Change in Motor Activity Log
timeFrame: 6 weeks from baseline
measure: Upper Extremity Fugl Meyer Assessment
timeFrame: 6 months follow-up
measure: Number of Participants With Adverse Events
timeFrame: 6 months follow-up
measure: Change in Fatigue Severity Scale
timeFrame: 6 weeks from baseline
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: 6 weeks from baseline
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Adriana B Conforto, MD Phd
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.