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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02454803




Registration number
NCT02454803
Ethics application status
Date submitted
22/05/2015
Date registered
27/05/2015
Date last updated
5/08/2019

Titles & IDs
Public title
Attainment of Person-centred Goals After Botulinum Toxin Treatment for Upper Limb Spasticity in Real Life Practice
Scientific 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
Secondary ID [1] 0 0
Y-79-52120-206
Universal Trial Number (UTN)
Trial acronym
ULIS III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Limb Spasticity 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient centred goal attainment will be assessed using the cumulated Goal Attainment Scale Total Score (GAS T score). - 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.
Timepoint [1] 0 0
From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary outcome [1] 0 0
To document the baseline patient characteristics and disease history. - 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.
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
To document the clinical management of the upper limb spasticity. - BoNT-A injection practices, concomitant drug and non-drug therapies.
Timepoint [2] 0 0
From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary outcome [3] 0 0
Patient centred goal attainment by goal area. - Assessed using the cumulated GAS T score of all goals assessed within each goal area.
Timepoint [3] 0 0
From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary outcome [4] 0 0
Evolution of goal changes across the study will be recorded alongside changes from baseline in the standardised outcome measures.
Timepoint [4] 0 0
From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary outcome [5] 0 0
Assessment of the correlations between patient centred goals and related standardised rating scales. - Using Goal Attainment Scaling Evaluation of Intensity (GASeous) and standardised outcome measures.
Timepoint [5] 0 0
From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary outcome [6] 0 0
Evaluation of change from baseline in the four domains of Disability Assessment Scale (DAS) as well as in the Principal Target of Treatment (PTT). - 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.
Timepoint [6] 0 0
From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary outcome [7] 0 0
Evolution of quality of life - 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).
Timepoint [7] 0 0
From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary outcome [8] 0 0
Health economic - 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.
Timepoint [8] 0 0
From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment hospital [2] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Austin Health Hospital - Heidelberg
Recruitment hospital [4] 0 0
Liverpool Brain Injury Rehabilitation Unit - Liverpool
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [6] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [7] 0 0
RPAH - Sidney
Recruitment hospital [8] 0 0
Westmead Hospital - Westmead
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
03124 - Camberwell
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
NSW2170 - Liverpool
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
02232 - Randwick
Recruitment postcode(s) [7] 0 0
02050 - Sidney
Recruitment postcode(s) [8] 0 0
NWS 2145 - Westmead
Recruitment postcode(s) [9] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
Austria
State/province [6] 0 0
Hermagor
Country [7] 0 0
Brazil
State/province [7] 0 0
Curitiba
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
São José do Rio Preto
Country [10] 0 0
France
State/province [10] 0 0
Angers
Country [11] 0 0
France
State/province [11] 0 0
Bordeaux
Country [12] 0 0
France
State/province [12] 0 0
Garches
Country [13] 0 0
France
State/province [13] 0 0
Grenoble
Country [14] 0 0
France
State/province [14] 0 0
Strasbourg
Country [15] 0 0
Germany
State/province [15] 0 0
Erlangen
Country [16] 0 0
Germany
State/province [16] 0 0
Leipzig
Country [17] 0 0
Germany
State/province [17] 0 0
Munich
Country [18] 0 0
Germany
State/province [18] 0 0
Wuerzburg
Country [19] 0 0
Hong Kong
State/province [19] 0 0
Hong Kong
Country [20] 0 0
Italy
State/province [20] 0 0
Ancona
Country [21] 0 0
Italy
State/province [21] 0 0
Bari
Country [22] 0 0
Italy
State/province [22] 0 0
Costa Masnaga
Country [23] 0 0
Italy
State/province [23] 0 0
Ferrara
Country [24] 0 0
Italy
State/province [24] 0 0
Messina
Country [25] 0 0
Italy
State/province [25] 0 0
Roma
Country [26] 0 0
Italy
State/province [26] 0 0
Sarzana
Country [27] 0 0
Mexico
State/province [27] 0 0
Ciudad de México
Country [28] 0 0
Mexico
State/province [28] 0 0
Mexico
Country [29] 0 0
Mexico
State/province [29] 0 0
Queretaro
Country [30] 0 0
Philippines
State/province [30] 0 0
Cebu City
Country [31] 0 0
Philippines
State/province [31] 0 0
Manila
Country [32] 0 0
Poland
State/province [32] 0 0
Krakow
Country [33] 0 0
Poland
State/province [33] 0 0
Warsaw
Country [34] 0 0
Portugal
State/province [34] 0 0
Alcoitao
Country [35] 0 0
Portugal
State/province [35] 0 0
Faro
Country [36] 0 0
Portugal
State/province [36] 0 0
Lisboa
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Barnaul
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Kazan
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Kemerovo
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Krasnoyarsk
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Moscow
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Saint Petersburg
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Saint-Petersburg
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taichung
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02454803
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications