NCT02228863

Trial name or title	Upper extremity rehabilitation using robot and botulinum toxin
Methods	RCT
Participants	Country: Republic of Korea Participants: estimated enrolment n = 348 Inclusion criteria: first‐ever stroke; shoulder or elbow flexor spasticity ≥ MAS 1+; being able to follow instructions from the investigator Exclusion criteria: history of surgery or fracture of affected upper limb; Botox injection within the last 6 months
Interventions	Experimental group: early InMotion and Botox (robotic rehabilitation with the InMotion device and Botox for 8 weeks; dosage not stated) Control group 1: Botox, then InMotion (robotic rehabilitation 4 weeks after botulinum toxin injection; dosage not stated) Control group 2: InMotion, then Botox (robotic rehabilitation from the baseline, then Botox injection at 4 weeks after baseline; dosage not stated) Control group 3: late Inmotion and Botox (no intervention, then robotic rehabilitation and Botox injection at 4 weeks after baseline; dosage not stated)
Outcomes	Outcomes will be collected at baseline and 4, 8, and 12 weeks from baseline Primary outcomes: FMA Secondary outcomes: kinematic data (InMotion) spasticity of elbow and shoulder joint (Modified Tardieu Scale) MRC of elbow and shoulder joint strength painless range of motion of elbow and shoulder joint numeric rating scale of pain of elbow and shoulder joint associated reaction rating scale surface electromyography data from bilateral upper extremities behavioural activation system/behavioral inhibition system scale Controlled Oral Word Association Test FMA SIS Beck Depression Inventory satisfaction about the intervention adverse events digit span test
Starting date	March 2014
Contact information	Joon‐Ho Shin, MS; asfreelyas@gmail.com
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