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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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Y-79-52120-206
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Universal Trial Number (UTN)
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Trial acronym
ULIS III
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Upper Limb Spasticity
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Patient centred goal attainment will be assessed using the cumulated Goal Attainment Scale Total Score (GAS T score).
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Assessment method [1]
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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.
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Timepoint [1]
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From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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Secondary outcome [1]
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To document the baseline patient characteristics and disease history.
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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To document the clinical management of the upper limb spasticity.
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Assessment method [2]
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BoNT-A injection practices, concomitant drug and non-drug therapies.
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Timepoint [2]
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From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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Secondary outcome [3]
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Patient centred goal attainment by goal area.
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Assessment method [3]
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Assessed using the cumulated GAS T score of all goals assessed within each goal area.
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Timepoint [3]
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From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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Secondary outcome [4]
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Evolution of goal changes across the study will be recorded alongside changes from baseline in the standardised outcome measures.
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Assessment method [4]
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Timepoint [4]
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From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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Secondary outcome [5]
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Assessment of the correlations between patient centred goals and related standardised rating scales.
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Assessment method [5]
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Using Goal Attainment Scaling Evaluation of Intensity (GASeous) and standardised outcome measures.
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Timepoint [5]
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From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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Secondary outcome [6]
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Evaluation of change from baseline in the four domains of Disability Assessment Scale (DAS) as well as in the Principal Target of Treatment (PTT).
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Assessment method [6]
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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.
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Timepoint [6]
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From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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Secondary outcome [7]
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Evolution of quality of life
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Assessment method [7]
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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).
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Timepoint [7]
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From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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Secondary outcome [8]
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Health economic
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Assessment method [8]
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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.
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Timepoint [8]
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From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/06/2019
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Sample size
Target
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Accrual to date
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Final
1004
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Epworth Rehabilitation Camberwell - Camberwell
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Recruitment hospital [2]
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St Vincent's Hospital - Darlinghurst
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Recruitment hospital [3]
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Austin Health Hospital - Heidelberg
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Recruitment hospital [4]
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Liverpool Brain Injury Rehabilitation Unit - Liverpool
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Recruitment hospital [5]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [6]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [7]
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RPAH - Sidney
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Recruitment hospital [8]
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Westmead Hospital - Westmead
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Recruitment hospital [9]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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03124 - Camberwell
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Recruitment postcode(s) [2]
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- Darlinghurst
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Recruitment postcode(s) [3]
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VIC 3084 - Heidelberg
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Recruitment postcode(s) [4]
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NSW2170 - Liverpool
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Recruitment postcode(s) [5]
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3052 - Parkville
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Recruitment postcode(s) [6]
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02232 - Randwick
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Recruitment postcode(s) [7]
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02050 - Sidney
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Recruitment postcode(s) [8]
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NWS 2145 - Westmead
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Recruitment postcode(s) [9]
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QLD 4102 - Woolloongabba
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Recruitment outside Australia
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United States of America
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Florida
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United States of America
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Illinois
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Kansas
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North Carolina
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Tennessee
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Austria
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Hermagor
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Brazil
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Curitiba
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Brazil
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Sao Paulo
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Brazil
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São José do Rio Preto
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France
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Angers
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France
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Bordeaux
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France
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Garches
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France
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France
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Strasbourg
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Germany
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Erlangen
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Germany
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Leipzig
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Germany
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Munich
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Germany
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Italy
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Ancona
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Italy
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Bari
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Italy
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Costa Masnaga
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Italy
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Ferrara
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Italy
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Messina
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Italy
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Roma
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Italy
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Sarzana
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Mexico
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Ciudad de México
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Mexico
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Mexico
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Mexico
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Queretaro
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Manila
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Krakow
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Warsaw
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Alcoitao
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Portugal
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Faro
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Portugal
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Lisboa
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Russian Federation
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Barnaul
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Taichung
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ipsen
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02454803
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Trial related presentations / publications
Khat'kova SE, Baikova A, Maisonobe P, Khasanova DR. [Impact of integrated upper limb spasticity management including repeat botulinum toxin type A (BoNT-A) injections on patient-centred goal attainment in real-life practice: results from the prospective, observational Upper Limb International Spasticity cohort study (ULIS-III) in a Russian subpopulation]. Zh Nevrol Psikhiatr Im S S Korsakova. 2021;121(11):39-48. doi: 10.17116/jnevro202112111139. Russian. Turner-Stokes L, Jacinto J, Fheodoroff K, Brashear A, Maisonobe P, Lysandropoulos A, Ashford S; Upper Limb International Spasticity-III (ULIS-III) study group. Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ULIS-III Study. J Rehabil Med. 2021 Jan 1;53(1):jrm00133. doi: 10.2340/16501977-2770. Turner-Stokes L, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Fheodoroff K. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). BMJ Open. 2016 Jun 17;6(6):e011157. doi: 10.1136/bmjopen-2016-011157.
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Public notes
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Contacts
Principal investigator
Name
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Ipsen Medical Director
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Address
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Ipsen
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02454803
Download to PDF