Results from the Upper Limb International Spasticity Study-II (ULIS-II): a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management

Abstract

ObjectiveTo describe real-life practice and person-centred outcomes in the treatment of poststroke upper limb spasticity with botulinum toxin A (BoNT-A).DesignObservational, prospective study.Setting84 secondary care centres in 22 countries.Participants456 adults (≥18 years) with poststroke upper limb spasticity treated with one cycle of BoNT-A.Methods/outcomesMuscle selection, BoNT-A preparation, injection technique and timing of follow-up were conducted according to routine practice for each centre. Primary outcome: achievement of the patient's primary goal for treatment using goal-attainment scaling (GAS). Measurements of spasticity, standardised outcome measures and global benefits were also recorded.ResultsThe median number of injected muscles was 5 (range 1–15) and the most frequently injected muscles were the long finger flexors, followed by biceps and brachioradialis. The median (range) follow-up time was 14 (2.6 to 32.3) weeks. The common primary treatment goals were passive function (132 (28.9%)), active function (104 (22.8%)), pain (61 (13.4%)), impairment (105 (23%)), involuntary movement (41 (9%)) and mobility (10 (2.2%)). Overall, 363 (79.6%) (95% CI 75.6% to 83.2%) patients achieved (or overachieved) their primary goal and 355 (75.4%) (95% CI 71.2% to 79.2%) achieved their secondary goal. Mean (SD) change from baseline in GAS T-scores was 17.6 (11.0) (95% CI 16.4 to 18.8; p<0.001). GAS T-scores were strongly correlated with global benefit and other standard measures (correlations of 0.38 and 0.63, respectively; p<0.001).ConclusionsBoNT-A demonstrated a clinically significant effect on goal attainment for the real-life management of upper-limb spasticity following stroke. The study confirms the feasibility of a common international data set to collect systematic prospective data, and of using GAS to capture person-centred outcomes relating to passive and active functions and to pain.RegistrationClinicalTrials.gov identifier: NCT01020500

Conceptualization and Development of the Leg Activity Measure (LegA) for Patient and Carer Reported Assessment of Activity in the Paretic Leg

“…Originally described by Kiresuk and Sherman (1968) in the 1960s, goal attainment scaling has been used in many areas of practice that warrant an individualized approach to outcome evaluation including rehabilitation (Hurn et al, 2006;Turner-Stokes et al, 2009a). It is increasingly used as a person-centred outcome measure in research evaluations of outcome following spasticity intervention (Ashford and Turner-Stokes, 2006;McCrory et al, 2009;Borg et al, 2011;Turner-Stokes et al, 2013;Turner-Stokes et al, 2013) and is recommended as a method of recording patient-reported outcomes in guidelines for management of spasticity with botulinum toxin (Royal College Of Physicians, British Society Of Rehabilitation Medicine, Chartered Society Of Physiotherapy, and Association Of Chartered Physiotherapist Interested In Neurology, 2009).…”

“…It is increasingly used as a person-centred outcome measure in research evaluations of outcome following spasticity intervention [16][17][18][19][20] , and is recommended as a method of recording patient-reported outcomes in guidelines for management of spasticity with Botulinum toxin 21 .…”

The study of the efficacy of Botulinum toxin type A in patients with poststroke upper-limb spasticity ULIS-II: an analysis of Russian patients

“…Учитывая большую когорту пациентов, проанализированную в международном исследовании ULIS-II, имеющиеся различия в методах лечения спастичности на фоне максимально персонифицированного подхода в оценке клинических результатов с помощью использования шкалы GAS, особый интерес для российских специалистов, занимающихся ботулинотерапией в лечении спастичности после инсульта, представляют результаты анализа данных российской группы пациентов. Целью данного анализа является сравнение данных российской подгруппы пациентов и ранее опубликованных результатов анализа общей популяции пациентов [21].…”

“…В российскую подгруппу были включены 26 (63,4%) мужчин и 15 (36,6%) женщин, средний возраст -53,9 года (от 28 до 76 лет). Демографические показатели российской подгруппы сходны с ранее опубликованными показателями международной популяции [21] (табл. 1).…”

A systematic review protocol to evaluate the psychometric properties of measures of function within adult neuro-rehabilitation

“…Other goals relate to increasing a person’s ability to perform activities and participate in their life situation [6, 11, 16, 18–20]. To date, no systematic review has done this.…”