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NCT Number: NCT02454803

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

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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Key information

Conditions

Upper Limb Spasticity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Epworth Rehabilitation Camberwell, Camberwell, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Patient has already been included in the current study, but was subsequently withdrawn.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: ULIS III

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 27, 2015
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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