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

NCT02292251.

Trial name or title Study to enhance motor acute recovery with intensive training after stroke
Methods RCTwith factorial assignment
Participants Estimated enrolment: 72
Inclusion criteria: age over 21 years; first or recurrent ischaemic stroke < 5 weeks prior to enrolment, confirmed by CT or MRI; residual unilateral arm weakness with UE‐FM between 6 and 40; informed consent; ability to understand the tasks involved
Exclusion criteria: prior stroke with resulting motor deficits; space‐occupying haemorrhagic transformation or associated intracranial haemorrhage; recent Botox injection to upper limb or planned Botox injection over the course of the 7‐month study duration; MoCA ≤ 20; history of physical or neurological condition that interferes with study procedures or assessment of motor function; contraindications to tDCS; inability to sit in a chair and perform upper limb exercises for one hour at a time; participation in another upper extremity rehab study or tDCS study during the study period; terminal illness; social or personal circumstances that interfere with the ability to return for therapy sessions and follow‐up assessments
Interventions 3 arms
  1. Active tDCS plus robot‐assisted arm therapy with the ArmeoPower device (30 hours in total)

  2. Sham tDCS plus robot‐assisted arm therapy with the ArmeoPower device (30 hours in total)

  3. Conventional occupational therapy that emphasises task‐oriented training

Outcomes Primary outcome measure
  1. Change in UE‐FM (from baseline to the end of intervention)


Secondary outcome measure
  1. Change in UE‐FM (from baseline to 3 months follow‐up)

Starting date May 2015
Contact information John Krakauer, MD
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Notes