RATIONALE AND DESIGN OF A MULTICENTRE, DOUBLE-BLIND, PROSPECTIVE, RANDOMIZED, EUROPEAN AND CANADIAN STUDY: EVALUATING PATIENT OUTCOMES AND COSTS OF MANAGING ADULTS WITH POST-STROKE FOCAL SPASTICITY

被引:27
作者
Borg, Jorgen [1 ]
Ward, Anthony B. [2 ]
Wissel, Joerg [3 ]
Kulkarni, Jai [4 ]
Sakel, Mohamed [5 ]
Ertzgaard, Per [6 ]
Akerlund, Per [7 ]
Reuter, Iris [8 ]
Herrmann, Christoph [9 ]
Satkunam, Lalith [10 ]
Wein, Theodore [11 ]
Girod, Isabelle [12 ]
Wright, Nicola [12 ]
机构
[1] Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Div Rehabil Med, SE-18288 Stockholm, Sweden
[2] Haywood Hosp, N Staffordshire Rehabil Ctr, Stoke On Trent, Staffs, England
[3] Kliniken Beelitz GmbH, Clin Dept Neurol Rehabil, Beelitz Heilstaetten, Germany
[4] Manchester Royal Infirm, Neurorehabil Dept, Manchester M13 9WL, Lancs, England
[5] E Kent Univ Fdn Hosp Trust, Neurorehabil Unit, Canterbury, Kent, England
[6] Linkoping Univ Hosp, Dept Rehabil Med, S-58185 Linkoping, Sweden
[7] Falu Lasarett, Dept Geriatr & Rehabil Med, Falun, Sweden
[8] Univ Giessen, Neurol Klin, Giessen, Germany
[9] Asklepios Kliniken Schildautal, Seesen, Germany
[10] Glenrose Rehabil Hosp, Edmonton, AB, Canada
[11] Montreal Gen Hosp, Stroke Prevent Clin, Div Neurol, Montreal, PQ H3G 1A4, Canada
[12] Allergan Ltd, Marlow Int, Marlow, Bucks, England
基金
美国国家卫生研究院;
关键词
botulinum toxin A; cost-effectiveness; goal attainment scaling; post-stroke spasticity; stroke rehabilitation; QUALITY-OF-LIFE; BOTULINUM TOXIN; STROKE PATIENTS; HEALTH; RELIABILITY; VALIDITY; SCALE; ASSOCIATION; PREVALENCE; MOVEMENT;
D O I
10.2340/16501977-0663
中图分类号
R49 [康复医学];
学科分类号
100215 ;
摘要
Objective: This report describes the design of a study aiming to provide evidence for the extended use of botulinum toxin A (BOTOX(R), Allergan Inc.) in focal post-stroke upper and lower limb spasticity and to evaluate the impact of incorporating botulinum toxin A treatment into the rehabilitation of patients with spasticity. Design: International, prospective, randomized, double-blind, placebo-controlled study with an open-label extension. Methods: Approximately 300 adults with a stroke occurring 23 months before screening, presenting with symptoms and signs of an upper motor neuron syndrome and focal spasticity-related functional impairment, were randomized to botulinum toxin A+standard care or placebo+standard care. Study medication was administered at baseline and again at Week 12 if required, with follow-up to 52 weeks. The primary endpoint was the number of patients who achieved their investigator-rated principal active functional goal (as measured by Goal Attainment Scaling), at 10 weeks after the second injection (Weeks 22-34) or at the 24-week visit if no second injection was administered. Secondary endpoints included changes from baseline in level of goal achievement, health-related quality of life and resource utilization. Conclusion: The BOTOX(R) Economic Spasticity Trial (BEST) will provide information regarding clinical and cost-effectiveness of botulinum toxin+standard care vs standard care alone in patients with upper and/or lower limb post-stroke spasticity typically seen in clinical practice.
引用
收藏
页码:15 / 22
页数:8
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