Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

Recruiting

Phase 4 Results N/A

Trial Description

Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention.

Conditions

Interventions

  • Early Inmotion and Botox Other
    Intervention Desc: Concomitant use of Inmotion and Botox from the baseline
    ARM 1: Kind: Experimental
    Label: Early Inmotion and Botox
    Description: Concomitant use of Inmotion and botulinum toxin from the baseline
  • Botox, then Inmotion Other
    Intervention Desc: At baseline Botox injection and 4 weeks after Inmotion
    ARM 1: Kind: Experimental
    Label: Botox, then Inmotion
    Description: Inmotion training 4 weeks after botulinum toxin injection
  • Inmotion, then Botox Other
    Intervention Desc: Inmotion from the baseline, then Botox injection at 4 weeks after baseline
    ARM 1: Kind: Experimental
    Label: Inmotion, then Botox
    Description: From the baseline Inmotion, then Botox injection at 4 weeks after baseline
  • Late Inmotion and Botox Other
    Intervention Desc: No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection
    ARM 1: Kind: Experimental
    Label: Late Inmotion and Botox
    Description: No intervention, then Inmotion and Botox injection at 4 weeks from the baseline

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change of Fugl-Meyer Assessment Fugl-Meyer Assessment change from baseline at 8 weeks No
Secondary Kinematic data Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline No
Secondary Spasticity of elbow and shoulder joint baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline No
Secondary Medical research council scale of elbow and shoulder joint strength baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline No
Secondary Painless range of motion of elbow and shoulder joint baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline No
Secondary numeric rating scale of pain of elbow and shoulder joint baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline No
Secondary Associated reaction rating scale baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline No
Secondary surface electromyography data from bilateral upper extremities baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline No
Secondary Behavioral activation system/behavioral inhition system scale baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline No
Secondary Controlled Oral Word Association Test baseline, 5ays of Inmotion, 20 days of Inmotion No
Secondary Fugl-Meyer Assessment Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline No
Secondary Stroke impact scale baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline No
Secondary Beck's depression index baseline, 4 weeks, 8 weeks, and 12 weeks from baseline No
Secondary Satisfaction about the intervention baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline No
Secondary Adverse event From baseline to 12 weeks from the baseline Yes
Secondary Digit span test baseline, 5days after Inmotion, 20 days after Inmotion. No

Sponsors