Study of Spastic Cocontractions and Limitation of Active Movements of the Upper Limb Before and After Treatment During Injection of Botulinum Toxin in Patients After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Measurement of spastic cocontraction index during active elbow extension
研究概览
简要总结
Following a stroke , 55% of the patients do not recover any traction of the upper limb and 30% a residual motricity not allowing a functional grip. For this last group of patients, there are major therapeutic issues to restore a functional grip.
The aim of the study is to relieved the spastic cocontractions before and after usual injection of botulinum toxin A at stroke patient.
详细描述
Descriptive study of spastic cocontraction index before and after botulinum toxin A injections during active elbow extension in chronic vascular hemiplegic patients.
The spastic cocontraction score will be compared between T1 (before the Botulinum toxin A injection) and T2 (4 weeks after the botulinum toxin A injection in the elbow flexors).
There is no control group. The patient is his own witness: the non-paretic side is considered as the physiological reference in terms of the level of spastic cocontractions.
Botulinum toxin A injections are performed in routine clinical practice in the Physical Medicine and Rehabilitation Department, following the recommendations in force. This treatment has been shown to be effective on spasticity in several high-level studies. The reduction of spasticity, evaluated clinically (Tardieu and Ashworth scale), is a criterion of efficacy of botulinum toxin A injections.
The evaluation of the effectiveness of botulinum toxin A injections on the other components of muscular hyperactivity, such as the reduction of spastic cocontraction during active movements, is poorly performed in clinical and clinical research. This protocol includes specific assessments to evaluate the evolution of spastic cocontraction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Having notified his non-opposition to participate in the search
- •Ischemic or hemorrhagic stroke of more than 6 months, cortical and / or subcortical;
- •Indication to the realization of an injection of Botulinum Toxin A in the flexor muscles of the elbow according to the usual clinical criteria: presence of a functional complaint or aesthetic expressed by the patient and related to hyperactivity muscular (spasticity or cocontraction) on the flexor muscles elbow, which is a focal treatment by injection of botulinum toxin;
- •Possibility of active extension of elbow> 20 °;
- •Patients naive to Botulinum Toxin A or more than 4 months of a first injection of Botulinum Toxin A, having targeted the elbow flexors.
排除标准
- •Passive limitation of elbow extension> 30 °;
- •Pain when performing active movements of flexion / extension of the elbow
- •Cognitive impairment limiting the comprehension of three basic instructions (proof test of the 3 papers of the MMS);
- •Evolutionary or decompensated neurological pathology; Ischemic or haemorrhagic stroke of less than 6 months;
- •General contraindication to the production of botulinum toxin; history of myasthenia gravis, Lambert Eaton syndrome; history of neuromuscular disease; surgery with curarization for less than 1 month; treatment with aminoglycoside, aminoquinoline or cyclosporine
- •Legal incapacity (safeguard of justice, guardianship).
结局指标
主要结局
Measurement of spastic cocontraction index during active elbow extension
时间窗: 2 hours
Measurement of spastic cocontraction index during active elbow extension, obtained from the electromyography signal of the extensor and flexor muscles of the elbow paretic side, between T1 and T2 (before / after the injection of Botulinum Toxin A).
次要结局
- Sensory balance of the upper limb(2 hours)
- Evaluation of the voluntary muscular force(2 hours)
- Evaluation of spasticity(2 hours)
- Limitation of Active Motion Angle Elbow Extension(2 hours)
- Fugl-Meyer score (motor selectivity)(2 hours)
- Functional abilities with the Wolf Motor Function Test score(2 hours)