NCT01767480

Trial name or title	Effects and mechanisms of intensive robot‐assisted therapy in patients with subacute stroke: outcomes in brain/movement reorganization, sensorimotor and daily functions, and physiological markers
Methods	RCT
Participants	Country: Taiwan Participants: estimated enrolment n = 90 Inclusion criteria: age between 20 and 75 years; first‐ever unilateral stroke; time since stroke < 3 months; initial motor part of upper limb FMA score ranging from 10 to 40; Mini‐Mental State Examination score > 23) Exclusion criteria: pregnant or breastfeeding; aphasia interfering with understanding of instructions; major health problems or poor physical condition; current participation in other research; contraindications to fMRI
Interventions	Experimental group 1 (higher‐intensity robotic training group; 1200 to 1800 repetitions during robot‐assisted functional rehabilitation with the Bi‐Manu‐Track device): 90 to 120 minutes per day for 5 days a week for 4 consecutive weeks Experimental group 2 (lower‐intensity robotic training group; 600 to 900 repetitions during robot‐assisted functional rehabilitation with the Bi‐Manu‐Track device): 90 to 120 minutes per day for 5 days a week for 4 consecutive weeks Control group (active): Neurodevelopmental techniques with emphasis on functional tasks
Outcomes	Outcomes will be measured at baseline and at the end of study Primary outcomes: FMA Motor Status Scale MAS MyotonPRO Muscle metabolism (near‐infrared spectroscopy) BBT Revised Nottingham Sensory Assessment FIM MAL ABILHAND questionnaire Adelaide Activites Profile EQ‐5D‐5L accelerometers fMRI kinematic analysis inflammatory markers oxidative stress markers erythrocyte deformability blood glucose indicators
Starting date	January 2013
Contact information	Ching‐Yi Wu, ScD; cywu@mail.cgu.edu.tw
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