NCT00276185Unknown3 期
Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2005年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Clinical Global Impression (CGI)
研究概览
简要总结
Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (<or = 3 months) in spasticity improve functional and motor tests compared with late injections (>or = 6 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age 18
- •Spastic hemiplegia after ischemic stroke (carotid occlusion) within the past 3 months.
- •Antispasticity medication stabilized for the last 30 days
- •Severe cognitive impairment such that patient is unable to provide scale assessment.
- •Significant spasticity impeding improvement by re-education for 2 months or less
- •Lack of muscular retraction defined by a minimal range of articular motion as :
- •finger : complete extension and rolling up
- •wrist : extension 40°/flexion : 45°
- •elbow : extension - 10°/flexion : 120°
- •shoulder : Enjalbert score 2 or more
- •Antagonist muscles (to spasticity) activity score 1 or more
- •Social Security benefits
排除标准
- •Ischemic stroke thought to be due to basilar or vertebral vessel occlusion
- •Known motor neuron or neuromuscular junction disease, disorders in which pain limits the ability to inject muscles (algodystrophy)
- •Absence of mobility in proximal part of upper limb that does not predict a functional gain
- •Minor stroke with non-disabling deficit or rapidly improving motor symptoms
- •other serious illness, e.g. severe hepatic, cardiac, or renal failure ; acute myocardial infarction ; or a complex disease that may confound treatment assessment
- •Treatment of spasticity by previous administration of botulinum toxin, if known
- •Known allergy to botulinum toxin
- •Currently participating in other research studies
结局指标
主要结局
Clinical Global Impression (CGI)
Box and blocks test
Enjalbert test
Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
Functional Independence Measure
Modified Ashworth scale (upper limb)
36-Item Short Form (SF-36) quality of life
Fugl-Meyer upper limb test
次要结局
- Range of pain
- Individual functional kinesitherapy
研究者
研究点 (2)
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