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

University of Sao Paulo General Hospital

Status: Terminated

Conditions: Stroke

Treatments: Other: Occupational Therapy; Device: Sham tDCS; Other: Physical Therapy; Device: Active tDCS; Device: Robotic Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02416791

513.207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

9 participants in 3 patient groups

Active tDCS + robotic therapy + physical therapy

Active Comparator group

Description:

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).

Treatment:

Device: Active tDCS

Device: Robotic Therapy

Other: Physical Therapy

sham tDCS + robotic therapy + physical therapy

Active Comparator group

Description:

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).

Treatment:

Device: Robotic Therapy

Device: Sham tDCS

Other: Physical Therapy

sham tDCS + physical therapy + occupational therapy

Experimental group

Description:

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).

Treatment:

Device: Sham tDCS

Other: Physical Therapy

Other: Occupational Therapy