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.
Study Type
OBSERVATIONAL
Enrollment
1,004
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.
Time frame: 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.
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.
Time frame: Baseline
To document the clinical management of the upper limb spasticity.
BoNT-A injection practices, concomitant drug and non-drug therapies.
Time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Patient centred goal attainment by goal area.
Assessed using the cumulated GAS T score of all goals assessed within each goal area.
Time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Design Neuroscience
Doral, Florida, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Kansas City Bone & Joint Clinic
Overland Park, Kansas, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Epworth Rehabilitation Camberwell
Camberwell, Australia
St Vincent's Hospital
Darlinghurst, Australia
Austin Health Hospital
Heidelberg, Australia
Liverpool Brain Injury Rehabilitation Unit
Liverpool, Australia
Royal Melbourne Hospital
Parkville, Australia
...and 47 more locations
Time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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.
Time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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).
Time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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.
Time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)