The aim of the study is to describe treatment outcomes of abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) treatments, after one injection of either treatment, in toxin-naïve adult patients with upper and/or lower limb spasticity at a single National Health Service (NHS) centre in the United Kingdom (UK).
Study Type
OBSERVATIONAL
Enrollment
114
North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
Stafford, United Kingdom
Average Goal Attainment Scale (GAS T) score 6 weeks
GAS, a method that evaluates the attainment of priority goals that are of importance to the patient and has been previously used for the management of patients with limb spasticity. Rating is performed for each domain from -3 "worse than at start" to +2 "much more than expected: clear improvement".
Time frame: 6 weeks
Average Goal Attainment Scale (GAS T) score 12 weeks
GAS, a method that evaluates the attainment of priority goals that are of importance to the patient and has been previously used for the management of patients with limb spasticity. Rating is performed for each domain from -3 "worse than at start" to +2 "much more than expected: clear improvement".
Time frame: 12 weeks
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Time frame: 12 weeks
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Time frame: 6 weeks
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Time frame: 12 weeks
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Time frame: 6 weeks
Average total dose
Time frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
Average dose per limb and per type of muscle injected
Time frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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Distribution of vials used
If Dysport® 300U / 500U, if Botox® 50U / 100U / 200U
Time frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
Distribution of localisation methods
Ultrasound, electrostimulation, palpation, electromyography
Time frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
Distribution of limb and type of muscles injected
Upper limb: shoulder girdle, shoulder, arm, forearm, hand; lower limb: hip, thigh, leg and foot
Time frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
Proportion of patients who require re-injection between aboBoNT-A and onaBoNT-A
Time frame: Week 6 and week 12 (re-injection)
Quality of Life (QoL)
The EQ-5D-VAS is used to evaluate patients' quality of life. EQ-5D-VAS is one component of the EQ-5D-5L, a generic, preference-based measure of health-related quality of life. The questions are answered based on how the subject is feeling "today".
Time frame: From baseline up to 12 weeks
Average number of unscheduled visits
Time frame: From baseline up to end of the study (up to 24 weeks)
Proportion of patients with ≥1 unscheduled visit
Time frame: From baseline up to end of the study (up to 24 weeks)
Proportion of patients with at least "the same", or at least "better" satisfaction with their treatment as measured using a Likert scale
A Likert scale is used to record patient's satisfaction with his/her progress, and the patient's "best response" (since index date) and "response now" (at the time of the review) on a five-category scale: From "Much worse" to "Much better"
Time frame: From baseline up to 12 weeks