NCT01655446

Trial name or title	Randomized trial of robotic rehabilitation, mirror therapy, and dose‐matched control intervention for upper‐limb rehabilitation in patients with chronic stroke: comparative efficacy and clinimetric study
Methods	RCT with factorial assignment
Participants	Country: Taiwan Participants: estimated enrolment n = 100 Inclusion criteria: unilateral stroke; onset more than 6 months; written informed consent; initial scores on the upper extremity FMA score of 25 to 56 or 18 to 50; Mini‐Mental State Examination ≥ 24 points; no upper limb fracture in the last 3 months Exclusion criteria: recurrent stroke or seizures during the intervention; serious or continuous pain on affected upper extremity; history of other neurological disease or severe orthopaedic condition
Interventions	Experimental group 1: robotic rehabilitation combined functional electrical stimulation (5 to 10 minutes of warm‐up, 1 hour of robotic rehabilitation with combined functional electrical stimulation, and 15 to 20 minutes of functional‐activities training 5 days a week for 4 weeks) Experimental group 2: mirror therapy (1 hour mirror therapy and 0.5 hour functional training per day, 5 days a week for 4 weeks); focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity Experimental group 3: robotic rehabilitation (5 to 10 minutes of warm‐up, 1 hour of robotic rehabilitation, and 15 to 20 minutes of functional‐activities training 5 days a week for 4 weeks) Control group 1 (active): conventional rehabilitation (participants in this group received a structured protocol based on occupational therapy such as neurodevelopmental techniques and task‐oriented approach for 1.5 hours per day, 5 days a week for 4 weeks) Control group 2 (placebo): like experimental group 1 but without any electrical current applied for 1.5 hours per day, 5 days a week for 4 weeks
Outcomes	Outcomes will be collected at baseline and at 4, 8, 16, and 28 weeks Primary outcomes: FMA MAS FIM movement smoothness (movement units) trajectory smoothness (total displacement) pre‐motor planning ability (percentage of peak velocity) speed of motor planning (reaction time) ARAT MRC Muscle tone (Myoton‐3) amount of the impaired arm movement outside the laboratory (accelerometer) produced force (peak velocity) trunk‐related kinematic variables Secondary outcomes: MAL ABILHAND questionnaire SIS 3.0 Nottingham Extended Activities of Daily Living Scale revised Nottingham Sensory Assessment FMA Sensory oxidative stress Multidimensional Fatigue Symptom Inventory
Starting date	August 2011
Contact information	Keh‐chung Lin, ScD; kehchunglin@ntu.edu.tw
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