Clinical Trial: Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Prospective, Non-interventional, Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity
Brief Summary: This is a prospective, non-interventional, observational study to collect data on the use of botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.
Detailed Summary:
Sponsor: Allergan
Current Primary Outcome:
- Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline [ Time Frame: Baseline ]The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.
- Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 [ Time Frame: Week 24 ]The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiff
Original Primary Outcome: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) [ Time Frame: 24 weeks ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Allergan
Dates:
Date Received: June 30, 2011
Date Started: June 2011
Date Completion:
Last Updated: December 13, 2013
Last Verified: December 2013