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. 2016 Mar 21;2016(3):CD009645. doi: 10.1002/14651858.CD009645.pub3

NCT02416791.

Trial name or title Robotic therapy and transcranial direct current stimulation in patients with stroke
Methods RCT with parallel‐group design
Participants Estimated enrolment: 51
Inclusion criteria: stroke onset 3 to 9 weeks prior to enrolment, radiologically confirmed; UE‐FM between 7 and 38; ability to provide informed consent; ability to comply with the schedule of interventions and evaluation of the protocol
Exclusion criteria: MAS > 3 in the paretic arm; upper limb plegia; uncontrolled medical conditions; pregnancy; seizures; pacemakers; other neurological disorders; psychiatric illnesses; aphasia compromising comprehension of the experimental protocol; MMSE < 23 for patients with > 1 year of education and MMSE < 19 for patients with > 1 year of education; hemineglect
Interventions 2 arms
  1. C‐tDCS over M1 of the affected hemisphere (1 mA for 20 minutes) prior to robotic training with the MIT‐Manus, followed by physical therapy for 40 minutes 3 times a week for 6 weeks

  2. Sham tDCS over M1 of the affected hemisphere prior to robotic training with the MIT‐Manus, followed by physical therapy for 40 minutes 3 times a week for 6 weeks

  3. Sham tDCS over M1 of the affected hemisphere prior to physical therapy for 40 minutes, followed by occupational therapy for 40 minutes 3 times a week for 6 weeks

Outcomes Primary outcome measures
  1. Change in UE‐FM (at 6 weeks)

  2. Adverse events (at 6 weeks)


Secondary outcome measures
  1. mRS (change from baseline to 6 weeks)

  2. NIHSS (change from baseline to 6 weeks)

  3. SIS (change from baseline to 6 weeks)

  4. MAS (change from baseline to 6 weeks)

  5. MAL (change from baseline to 6 weeks)

  6. UE‐FM (at 6 months)

  7. Adverse events (at 6 months)

  8. FSS (change from baseline to 6 weeks)

  9. Pittsburgh Sleep Quality Index (change from baseline to 6 weeks)

Starting date June 2015
Contact information Thais Midori K Tokuno
Hospital das Clínicas
São Paulo, SP, Brazil, 05403900
Notes