CompletedInterventionalPhase 2Updated Mar 19, 2024
Upper Extremity Rehabilitation Using Robot and Botulinum Toxin | NCT02228863 | Trialant
Unknown statusInterventionalPhase 4Updated Aug 29, 2014
Upper Extremity Rehabilitation Using Robot and Botulinum Toxin
ClinicalTrials.gov ID
NCT02228863
Lead Sponsor
National Rehabilitation Center, Seoul, KoreaOTHER_GOV
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 4
Enrollment
348Estimated
Last Update Posted
Aug 29, 2014Estimated
Start Date
Mar 2014
Primary Completion Date
Feb 2017Estimated
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.
Stroke
Spasticity
Early Inmotion and Botox
Botox, then Inmotion
Inmotion, then Botox
Late Inmotion and Botox
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Joon-Ho Shin, MSContact
asfreelyas@gmail.com82-2-901-1884
National Rehabilitation CenterRecruiting
Seoul, Seoul 142884, South Korea
Joon-Ho Shin, MSContact
asfreelyas@gmail.com82-901-1884
Joon-Ho Shin, MSPrincipal Investigator
Lead Sponsor
National Rehabilitation Center, Seoul, KoreaOTHER_GOV