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

Conditions

Upper Limb Spasticity

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.

Turner-Stokes L, Fheodoroff K, Jacinto J, Beneteau M, Maisonobe P, Hannes C, Ashford S.

2026-04-28

10.2340/jrm.v58.45139

2648 Goal attainment with integrated upper-limb spasticity management including botulinum toxin A (BoNT-A): sub-analysis of Australian data from the ULIS-III study

Edwin Luk, John Olver, Rachael Nunan, Ian Baguley, John Estell et al. (8 authors)

2023-08-01

10.1136/bmjno-2023-anzan.71

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.

Turner-Stokes L, Jacinto J, Fheodoroff K, Brashear A, Maisonobe P, Lysandropoulos A, Ashford S, Upper Limb International Spasticity-III (ULIS-III) study group.

2021-01-0115 citations

10.2340/16501977-2770

[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].

Khat'kova SE, Baikova A, Maisonobe P, Khasanova DR.

2021-01-011 citations

10.17116/jnevro202112111139

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)

Lynne Turner‐Stokes, Stephen Ashford, Jorge Jacinto, Pascal Maisonobe, Jovita Balcaitiene et al. (6 authors)

BMJ Open2016-06-0134 citations

10.1136/bmjopen-2016-011157

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

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

Measure	Time frame	Description
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)	BoNT-A injection practices, concomitant drug and non-drug therapies.
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)	Assessed using the cumulated GAS T score of all goals assessed within each goal area.
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)	—
To document the baseline patient characteristics and disease history.	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.
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)	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.
Evolution of quality of life	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).
Health economic	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.
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)	Using Goal Attainment Scaling Evaluation of Intensity (GASeous) and standardised outcome measures.

Countries

Australia, Austria, Brazil, France, Germany, Hong Kong, Italy, Mexico, Philippines, Poland, Portugal, Russia, Taiwan, United States

Outcome results