Upper Extremity Rehabilitation Using Robot and Botulinum Toxin
Phase 4
- Conditions
- StrokeSpasticity
- Interventions
- Other: Late Inmotion and BotoxOther: Inmotion, then BotoxOther: Early Inmotion and BotoxOther: Botox, then Inmotion
- Registration Number
- NCT02228863
- Lead Sponsor
- National Rehabilitation Center, Seoul, Korea
- Brief Summary
Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 348
Inclusion Criteria
- Hemiplegic patients secondary to first cerebrovascular accidents
- Shoulder or Elbow flexor spasticity above or modified ashworth scale 1+
- Cognitively intact enough to understand and follow the instructions from the investigator
Exclusion Criteria
- History of surgery of affected upper limb
- Fracture of affected upper limb
- Recent history of botulinum toxin injection within 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Late Inmotion and Botox Late Inmotion and Botox No intervention, then Inmotion and Botox injection at 4 weeks from the baseline Inmotion, then Botox Inmotion, then Botox From the baseline Inmotion, then Botox injection at 4 weeks after baseline Early Inmotion and Botox Early Inmotion and Botox Concomitant use of Inmotion and botulinum toxin from the baseline Botox, then Inmotion Botox, then Inmotion Inmotion training 4 weeks after botulinum toxin injection
- Primary Outcome Measures
Name Time Method Change of Fugl-Meyer Assessment Fugl-Meyer Assessment change from baseline at 8 weeks
- Secondary Outcome Measures
Name Time Method Kinematic data Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion
surface electromyography data from bilateral upper extremities baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline Fugl-Meyer Assessment Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline Satisfaction about the intervention baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline Adverse event From baseline to 12 weeks from the baseline Spasticity of elbow and shoulder joint baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline Modified Ashworth scale of elbow and shoulder joint Modified Tardieu scale of elbow and shoulder joint
Painless range of motion of elbow and shoulder joint baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline Associated reaction rating scale baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline Controlled Oral Word Association Test baseline, 5ays of Inmotion, 20 days of Inmotion Controlled Oral Word Association Test during baseline, 5 days of Inmotion, 20 days of Inmotion.
The test was done at rest and with Inmotion trialBeck's depression index baseline, 4 weeks, 8 weeks, and 12 weeks from baseline Medical research council scale of elbow and shoulder joint strength baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline numeric rating scale of pain of elbow and shoulder joint baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline Behavioral activation system/behavioral inhition system scale baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline In terms of motivation
Stroke impact scale baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline Digit span test baseline, 5days after Inmotion, 20 days after Inmotion. 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
Trial Locations
- Locations (1)
National Rehabilitation Center
🇰🇷Seoul, Korea, Republic of