An International, Multicentre, Observational, Prospective, Longitudinal Cohort Study to Assess the Impact of Integrated Upper Limb Spasticity Management Including the Use of BoNT-A- Injections on Patient-centred Goal Attainment in Real Life Practice - ULIS III

Ipsen57 sites in 13 countries1,004 target enrollmentJanuary 2015

ConditionsUpper Limb Spasticity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Upper Limb Spasticity
Sponsor: Ipsen
Enrollment: 1004
Locations: 57
Primary Endpoint: Patient centred goal attainment will be assessed using the cumulated Goal Attainment Scale Total Score (GAS T score).
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose for this study is to understand the effect of botulinum toxin as a treatment integrated in the management of spasticity (stiffness) in the arm and/or hand, arising from any neurological condition. The study will look at the types of goals that people choose for treatment, and the extent to which these are achieved in different individuals.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

June 3, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients with ULS, in whom a decision has already been made to inject botulinum toxin A (BoNT A).
•Patient has provided written informed consent for collection of the data.

Exclusion Criteria

•Participation in any interventional clinical study of ULS within the 12 weeks prior to the inclusion visit (Visit 1).
•Patient has already been included in the current study, but was subsequently withdrawn.

Outcomes

Primary Outcomes

Patient centred goal attainment will be assessed using the cumulated Goal Attainment Scale Total Score (GAS T score).

Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)

Goal attainment will be recorded on a five point numerical scale (range -2 to +2) and goal scores combined to give an aggregated T score.

Secondary Outcomes

To document the baseline patient characteristics and disease history.(Baseline)
Patient centred goal attainment by goal area.(From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection))
Evolution of goal changes across the study will be recorded alongside changes from baseline in the standardised outcome measures.(From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection))
Assessment of the correlations between patient centred goals and related standardised rating scales.(From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection))
Evaluation of change from baseline in the four domains of Disability Assessment Scale (DAS) as well as in the Principal Target of Treatment (PTT).(From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection))
Evolution of quality of life(From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection))
Health economic(From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection))
To document the clinical management of the upper limb spasticity.(From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection))