NCT01907139

Trial name or title	Comparative efficacy research of robot‐assisted therapy with and without constraint‐induced therapy in stroke rehabilitation: does the combined therapy improve outcomes compared with monotherapy?
Methods	RCT with factorial assignment
Participants	Country: Taiwan Participants: estimated enrolment n = 80 Inclusion criteria: aged between 20 to 80 years; unilateral first‐ever stroke; 6 months from onset; initial upper extremity FMA score of 20 to 56; minimal motor criteria to receive constraint‐induced therapy (i.e. ≥ 100 wrist extension and ≥ 100 extension at the thumb and any other 2 digits); MAS ≤ 3 of the affected upper extremity; no upper limb fracture within the last 3 months; Mini‐Mental State Examination ≥ 24 points; written informed consent Exclusion criteria: major medical problems or poor physical condition that would interfere with participation; excessive pain in any joint that might limit participation
Interventions	Experimental group 1: distributed constraint‐induced therapy (placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper limb in functional tasks for 1.5 hours/weekday over 4 weeks) Control group (active): dose‐matched control therapy for 1.5 hours/weekday over 4 weeks Experimental group 2: robot‐assisted therapy (ArmeoSpring) for 1.5 hours/weekday over 4 weeks Experimental group 3: robot‐assisted therapy (ArmeoSpring) for 1.5 hours/weekday over 2 weeks plus distributed constraint‐induced therapy for 1.5 hours/weekday over 2 weeks
Outcomes	Outcomes will be collected at baseline and at 2 and 4 weeks Primary outcomes: FMA WMFT FIM MAL SIS 3.0 Secondary outcomes: MRC MAS Revised Nottingham Sensory Assessment muscle tone (MyotonPRO) activity (actigraphy) visual analogue scale for assessing postexertional fatigue and pain urinary 8‐hydroxydeoxyguanosine kinematic analysis
Starting date	August 2013
Contact information	Keh‐chung Lin, ScD; School of Occupational Therapy, College of Medicine, National Taiwan University, Taiwan Yi‐shiung Horng, PhD; Buddhist Tzu Chi General Hospital Taipei Branch
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