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Attainment of Person-centred Goals After Botulinum Toxin Treatment for Upper Limb Spasticity in Real Life Practice (ULIS III)

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ClinicalTrials.gov Identifier: NCT02454803
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease
Upper Limb Spasticity

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Study Type : Observational
Actual Enrollment : 1004 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : January 2015
Actual Primary Completion Date : June 3, 2019
Actual Study Completion Date : June 3, 2019



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To document the baseline patient characteristics and disease history. [ Time Frame: Baseline ]
    Muscle tone will be evaluated using the Modified Ashworth Scale (MAS). Severity of different aspects of impairment in patients with neurological damage will be evaluated using the Upper Limb Spasticity Neurological Impairment Scale (ULS-NIS) recorded for both upper limbs.

  2. To document the clinical management of the upper limb spasticity. [ Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) ]
    BoNT-A injection practices, concomitant drug and non-drug therapies.

  3. Patient centred goal attainment by goal area. [ Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) ]
    Assessed using the cumulated GAS T score of all goals assessed within each goal area.

  4. Evolution of goal changes across the study will be recorded alongside changes from baseline in the standardised outcome measures. [ Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) ]
  5. Assessment of the correlations between patient centred goals and related standardised rating scales. [ Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) ]
    Using Goal Attainment Scaling Evaluation of Intensity (GASeous) and standardised outcome measures.

  6. Evaluation of change from baseline in the four domains of Disability Assessment Scale (DAS) as well as in the Principal Target of Treatment (PTT). [ Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) ]
    The DAS will be used at each visit to determine the extent of functional impairment in four domains: hygiene, dressing, limb position and pain. Impairment is assessed on a four point scale (range 0 to 3, where 0=no disability, and 3=severe disability). The PTT will be defined at each visit, based on one of the four DAS domains.

  7. Evolution of quality of life [ Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) ]
    Assessed at each visit in a subpopulation of English-native speaker patients in Anglophone countries based on two different quality of life instruments, EuroQol 5 Dimensions, 5 levels (EQ 5D 5L) and Spasticity Related Quality of Life Tool (SQoL 6D).

  8. Health economic [ Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) ]
    Health economic analysis will include changes in concomitant treatments, changes in patient employment status, maintenance of health care (by nurse, caregiver etc) and utility data derived from EQ-5D 5L, DAS, GAS and SQoL-6D.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient suffering from upper limb spasticity (ULS) seen in clinic, hospital and/or rehabilitation centers.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454803


Locations
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Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02454803    
Other Study ID Numbers: Y-79-52120-206
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases