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.
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 Spasticity Following Stroke
Conditions
Study Type
Observational
Study Design
- Observational Model: Cohort
- Time Perspective: Prospective
Further Details
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall attainment of the treatment goals using the GAS T score
[ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ] - Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test)
[ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ] - Global assessment of benefits by both the investigator and the subject (or guardian)
[ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ]
Study Start
January 2010 – November 2010
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
- Sampling Method: Non-Probability Sample
Inclusion Criteria:
- Upper limb spasticity following stroke
- At least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion
- Decision already been agreed to inject BoNT-A
- Agreement with the subject on goal setting
Exclusion Criteria:
- Contraindications to any BoNT-A preparations
Total Enrolment
450
Contact Details
Ipsen Recruitment Enquiries
clinical.trials@ipsen.com
Australia Locations
Rankin Park – Newcastle
St Vincent’s Hospital – Sydney
Northshore Private Hospital – Sydney
St Joseph’s Hospital – Sydney
Ryde Rehabilitation Center – Sydney
Royal Prince Alfred Hospital – Sydney
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