Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
348
Concomitant use of Inmotion and Botox from the baseline
At baseline Botox injection and 4 weeks after Inmotion
Inmotion from the baseline, then Botox injection at 4 weeks after baseline
National Rehabilitation Center
Seoul, Seoul, South Korea
RECRUITINGChange of Fugl-Meyer Assessment
Time frame: Fugl-Meyer Assessment change from baseline at 8 weeks
Kinematic data
Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Spasticity of elbow and shoulder joint
Modified Ashworth scale of elbow and shoulder joint Modified Tardieu scale of elbow and shoulder joint
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Medical research council scale of elbow and shoulder joint strength
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Painless range of motion of elbow and shoulder joint
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
numeric rating scale of pain of elbow and shoulder joint
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Associated reaction rating scale
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
surface electromyography data from bilateral upper extremities
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Behavioral activation system/behavioral inhition system scale
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No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection
In terms of motivation
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Controlled Oral Word Association Test
Controlled Oral Word Association Test during baseline, 5 days of Inmotion, 20 days of Inmotion. The test was done at rest and with Inmotion trial
Time frame: baseline, 5ays of Inmotion, 20 days of Inmotion
Fugl-Meyer Assessment
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Stroke impact scale
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Beck's depression index
Time frame: baseline, 4 weeks, 8 weeks, and 12 weeks from baseline
Satisfaction about the intervention
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Adverse event
Time frame: From baseline to 12 weeks from the baseline
Digit span test
Digit span test(forward, backward) during baseline, 5 days of Inmotion, 20 days of Inmotion. The test was done at rest and with Inmotion trial
Time frame: baseline, 5days after Inmotion, 20 days after Inmotion.