Clinical Trial: To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: An International, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Upper Limb
Brief Summary: The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.
Detailed Summary:
Sponsor: Ipsen
Current Primary Outcome: Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS) following one BoNT-A injection cycle in accordance with routine practices [ Time Frame: Around 3 to 5 months post injection ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall attainment of the treatment goals using the GAS T score [ Time Frame: Around 3 to 5 months post injection ]
- Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test) [ Time Frame: Around 3 to 5 months post injection ]
- Global assessment of benefits by both the investigator and the subject (or guardian) [ Time Frame: Around 3 to 5 months post injection ]
Original Secondary Outcome: Same as current
Information By: Ipsen
Dates:
Date Received: November 24, 2009
Date Started: January 2010
Date Completion:
Last Updated: June 20, 2011
Last Verified: June 2011
