PND85 EFFICACY AND SAFETY OF ABOBOTULINUMTOXINA IN ADULTS WITH UPPER LIMB SPASTICITY AFTER STROKE: A SYSTEMATIC REVIEW

Introduction This systematic review appraises the measurement quality of tools which assess activity and/or participation in adults with upper limb spasticity arising from neurological impairment, including methodological quality of the psychometric studies. Differences in the measurement quality of the tools for adults with a neurological impairment, but without upper limb spasticity, is also presented. Methods 29 measurement tools identified in a published review were appraised in this systematic review. For each identified tool, we searched 3 databases (Medline, Embase, CINAHL) to identify psychometric studies completed with neurorehabilitation samples. Methodological quality of instrument evaluations was assessed with use of the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist. Synthesis of ratings allowed an overall rating of the psychometric evidence for each measurement tool to be calculated. Results 149 articles describing the development or evaluation of psychometric properties of 22 activity and/or participation measurement tools were included. Evidence specific to tool use for adults with spasticity was identified within only 15 of the 149 articles and provided evidence for 9 measurement tools only. Overall, COSMIN appraisal highlighted a lack of evidence of measurement quality. Synthesis of ratings demonstrated all measures had psychometric weaknesses or gaps in evidence (particularly for use of tools with adults with spasticity). Conclusions The systematic search, appraisal and synthesis revealed that currently there is insufficient measurement quality evidence to recommend one tool over another. Notwithstanding this conclusion, newer tools specifically designed for use with people with neurological conditions who have upper limb spasticity, have emergent measurement properties that warrant further research. Systematic review registration PROSPERO CRD42014013190.

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Efficacy and safety of onabotulinumtoxinA with standardized occupational therapy for treatment of pediatric upper limb spasticity: Phase III placebo-controlled randomized trial

Neurorehabilitation ◽

10.3233/nre-210071 ◽

2021 ◽

pp. 1-11

Author(s):

Rozalina Dimitrova ◽

Emily McCusker ◽

Mark Gormley ◽

Darcy Fehlings ◽

Katharine E. Alter ◽

...

Keyword(s):

Occupational Therapy ◽

Upper Limb ◽

Goal Attainment ◽

Phase Iii ◽

Efficacy And Safety ◽

Secondary Endpoints ◽

Limb Spasticity ◽

Goal Attainment Scale ◽

Global Impression Of Change ◽

Post Hoc

BACKGROUND: This is the first large study of onabotulinumtoxinA as treatment for pediatric upper limb spasticity. OBJECTIVE: Evaluate efficacy and safety of a single treatment with onabotulinumtoxinA plus occupational therapy (OT). METHODS: In this registrational phase 3, multinational study (NCT01603602), participants were randomized 1:1:1 to onabotulinumtoxinA 3 U/kg/OT, 6 U/kg/OT, or placebo/OT. Primary endpoint was average change from baseline at weeks 4 and 6 in Modified Ashworth Scale-Bohannon (MAS) score. Secondary endpoints included Modified Tardieu Scale (MTS), Clinical Global Impression of Change (CGI) and functional Goal Attainment Scale (GAS). RESULTS: 235 participants were randomized. At weeks 4 and 6, onabotulinumtoxinA groups had greater mean reductions in MAS (both –1.9; p < 0.001) versus placebo (–1.2). OnabotulinumtoxinA doses improved dynamic tone per MTS. Mean CGI at weeks 4 and 6 was unchanged in the overall population, but improved in a post hoc analysis of patients with a single affected UL muscle group (elbow or wrist). GAS score for passive goals was significantly higher for 6 U/kg versus placebo at week 12. Most AEs were mild/moderate in severity; overall incidence was similar between groups. CONCLUSIONS: OnabotulinumtoxinA (3 and 6 U/kg) was safe and effective in reducing upper limb spasticity in pediatric participants.

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