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临床试验/NCT01882556
NCT01882556已完成2 期

Is it Clinically Effective to Treat Arm Flexor Spasticity, With Botulinum Toxin - Type A (BoNTA) and Physiotherapy, as Soon as Signs of Abnormal Muscle Activity Are Observed?

Sandwell & West Birmingham Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Action Research Arm Test

研究概览

简要总结

Patients who survive a stroke are often left with an arm that cannot be used. One reason for this is that the muscles affected by the stroke become overactive. This is known as spasticity. Such unwanted muscle overactivity, if left untreated or poorly managed, can lead to limb deformities. For example, the wrist and fingers in the arm affected by spasticity become stiff and curl into a fist and the hand cannot be used for any functional purpose. Palm hygiene can become difficult and patients find this deformity unsightly and painful. Botulinum toxin (BT) has been shown to reduce muscle overactivity and is licensed for this purpose. In current practice this treatment is often used as a last line of defence. Although BT can reduce the muscle overactivity, when injected using current protocols, it seems to have little impact on the recovery of function and/or treating the limb deformities and pain. If BT can be given in the early stages of a stroke, i.e. as soon as the muscle overactivity is observed, then we will be able to treat spasticity and may prevent the limb deformities and pain from developing. We may also be able to assist the recovery of arm movement in some of the patients who would otherwise not have regained this. In addition to benefiting the patient, the prevention of secondary complications by early treatment may reduce the costs of long term care to the NHS . We hope to discover if our plan of providing early treatment with BT is more effective than the current approach. If we demonstrate that the treatment is effective we will be able to introduce this new method almost immediately within the NHS through our collaboration with doctors and therapists who are actively treating patients with this condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years of age.
  • Patients with stroke due to a primary cerebral haemorrhage/infarction, subarachnoid haemorrhage producing an upper motor syndrome affecting one body side which results in a hemiplegia
  • Capable of providing informed consent directly or indirectly, or, consent obtainable from next of kin or legal representative
  • No useful arm function (i.e. less than or equal to 2 on the grasp subsection of the Action Research Arm Test) at onset of spasticity

排除标准

  • Significant musculoskeletal conditions that affected upper limb function prior to the stroke
  • Unconscious or moribund during the screening period
  • Recovery of useful arm function (a score of 3 or more in the grasp section of the Action Research Arm Test) prior to injections
  • Patients with contraindications to electrical stimulation including active implants (e.g. cardiac assist devices), metal implants at site of stimulation, scar tissue/cancerous tissue at site of stimulation, uncontrolled epilepsy, deep vein thrombosis in limb / muscle being stimulated and pregnancy (or planned pregnancy)
  • Previous upper motor neurone syndrome or hypertonicity due to multiple sclerosis, spinal cord injury or other neurological disorder
  • Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin)
  • Patients with myasthenia gravis or Eaton Lambert Syndrome or other neuromuscular junction or myopathic disorder
  • Patients with infection at the proposed injection site(s)
  • Patients who are pregnant or may become pregnant at the time of the proposed injections and for the duration of the study
  • Current treatment with any antispasticity agent or previous injection with BOTOX

研究组 & 干预措施

Botulinum Toxin - Type A (onabotulinumtoxinA)

Experimental

Botulinum Toxin - Type A. One set of injections of up to 200 Units of Botox (Allergan). Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.

干预措施: onabotulinumtoxinA (Drug)

0.9% NaCl Saline Injection

Placebo Comparator

Saline - Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.

干预措施: Placebo (Drug)

结局指标

主要结局

Action Research Arm Test

时间窗: 6 Months

次要结局

  • Strength and Fatigue(6 Months)
  • Stiffness and passive range of movement.(6 months)
  • Spasticity(6 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cameron Lindsay

Mr

Sandwell & West Birmingham Hospitals NHS Trust

研究点 (1)

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