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

NCT02254616.

Trial name or title Hybrid approach to mirror therapy and transcranial direct current stimulation for stroke recovery: a follow up study on brain reorganisation, motor performance of upper extremity, daily function, and activity participation
Methods Randomised controlled trial with parallel‐group design
Participants Estimated enrolment: 80
Inclusion criteria: first stroke in cortical regions; time since stroke > 6 months prior to enrolment; initial UE‐FM score between 24 to 52; MAS ≤ 2 in any joints of the affected arm; MMSE ≥ 24; willing to sign the informed consent
Exclusion criteria: aphasia interfering with understanding instructions; visual/attention impairments that might interfere with the seeing of mirror illusion, including hemineglect/hemianopsia; currently participation in any other research; previous brain neurosurgery; metallic implants within the brain
Interventions 4 arms

  1. Active tDCS (1.5 mA for 20 minutes) followed by mirror therapy (40 minutes) and functional training (30 minutes) during the first 2 weeks, and 60 minutes pure mirror therapy followed by 30 minutes functional training during the last 2 weeks

  2. Sham tDCS (20 minutes) followed by mirror therapy (40 minutes) and functional training (30 minutes) during the first 2 weeks, and 60 minutes pure mirror therapy followed by 30 minutes functional training during the last 2 weeks

  3. Mirror therapy for 60 minutes per session followed by 30 minutes functional training

  4. 60 minutes conventional stroke rehabilitation intervention followed by 30 minutes functional training
Outcomes Primary outcome measures

  1. Change in UE‐FM (at baseline, 2, 4, 16 and 28 weeks)

  2. Change in WMFT (at baseline, 2 and 4 weeks)

  3. Change in MAL (at baseline, 2, 4, 16 and 28 weeks)

  4. Change in rNSA (at baseline and 4 weeks)


Secondary outcome measures

  1. Change in AAP (at baseline, 4, 16 and 28 weeks)

  2. Change in 10MWT (at baseline and 4 weeks)

  3. Change in actigraphy (at baseline and 4 weeks)

  4. Change in kinematic analysis (at baseline and 4 weeks)

  5. Change of hand strength (at baseline, 2 and 4 weeks)

  6. Change of Stroop Test (at baseline and 4 weeks)

  7. Change of pressure pain threshold (at baseline and 4 weeks)
Starting date August 2014
Contact information Ching‐Yi Wu, ScD
Chang Gung Memorial Hospital
Kwei‐Shan, Tao‐Yuan, Taiwan, 333
Notes