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临床试验/NCT02719483
NCT02719483已完成不适用

Applied Research in Children With Spastic Cerebral Palsy in the Extracorporeal Shock Wave Therapy

The First Hospital of Jilin University0 个研究点目标入组 66 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
主要终点
Modified Ashworth Scale (MAS) grade of the plantar flexor muscles

研究概览

简要总结

The purpose of this study is to determine whether radial extracorporeal shock wave therapy in combination with traditional physical therapy is safe and effective for the management of spastic plantar flexor muscles in patients with cerebral palsy younger than averaged three years of age.

详细描述

Cerebral palsy (CP) is a clinical syndrome characterized by a persistent disorder of posture or movement caused by a non-progressive disorder of the immature brain. The prevalence of CP has been reported to be between 1.86 cases per 1,000 population in the United Kingdom and 3.6 cases per 1,000 in 8-year-old children in the United States, with little variation among Western nations. In a very recent systematic review analyzing a total of 49 studies, the pooled overall prevalence of CP was 2.11 cases per 1,000 live births. Rates of CP in population-based settings in India and China gave figures of 2-2.8 cases per 1,000 births. A systematic literature review for a period spanning between 1965 and 2004 found CP more prevalent in more deprived socio-economic populations. The same study identified low birthweight, intrauterine infections and multiple gestation as the most important risk factors for CP.

Most children with CP suffer from spasticity as the main motor disorder. Spasticity is a major challenge for rehabilitation of children with CP. This is because spasticity can cause pain, prevent or hamper function and may disturb sleep. Spasticity of plantar flexor muscles is a particular problem in CP because it causes toe walking. This can result in major functional implications such as disturbances in balance and walking, and interfere with gross motor function.

The management of spasticity in CP is complex and is a major challenge to the treatment team. The ultimate goal of any therapy program must be to achieve the child's maximum potential in motor skills. Unfortunately, the scientific evidence for various physical therapy treatment options for children with CP is limited. Botulinum neurotoxin (BoNT) is a widely used and effective pharmacological treatment for focal muscle over-activity. An alternative to BoNT treatment is focal intramuscular treatment with phenol and alcohol, with the aim to improve activity limitations and other outcomes in children and adults with spasticity. However, focal intramuscular injection of BoNT, phenol and alcohol is not without problems: (i) BoNT is expensive and not available in many countries; (ii) a significant risk of focal intramuscular injection of alcohol and phenol is persisting pain; and (iii) all these procedures are invasive and, thus, not without risk when applied under difficult hygienic conditions. With regard to post-stroke spasticity, a recent Cochrane review concluded that, at best, there was 'low level' evidence for the effectiveness of outpatient multidisciplinary rehabilitation in improving active function and impairments following BoNT treatment for upper limb spasticity in adults with chronic stroke.

Orthopedic surgery is considered a last resort in managing spasticity in children with CP, but is not an option for managing spasticity per se. Instead, it is used to help correct the secondary problems that occur with growth alongside spastic muscles and poor motion control. Those problems include muscle shortening, joints contractures and bony deformities.

Recently, extracorporeal shock wave therapy (ESWT) has become an alternative in the treatment of spasticity. A byproduct of extracorporeal shock wave lithotripsy, ESWT has emerged as a noninvasive management option for tendon and other pathologies of the musculoskeletal system with minimal unwanted side effects such as temporary skin redness and pain during treatment. Prior studies on tendinopathy showed that ESWT can be as or more effective than other forms of treatment such as eccentric exercise, traditional physiotherapy, steroid injections and surgery. There are two different types of extracorporeal shock waves - focused (fESWT) and radial (rESWT) - and several modes of operation of focused and radial extracorporeal shock wave generators.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Months 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • diagnosis of cerebral palsy
  • spasticity of plantar flexor muscles greater than Grade 1 and up to Grade 4 according to the modified Ashworth scale
  • availability to attend the hospital during the treatment and follow-up assessments

排除标准

  • fixed contractures or deformities at the left ankle
  • myopathies
  • clinical signs of myopathy and neuropathy
  • treatment with shock waves in the past
  • treatment with Botulinum neurotoxin A and/or focal intramuscular treatment with phenol and alcohol in the past
  • previous surgery of the left foot, ankle and leg
  • treatment with drugs for spasticity control
  • infection or tumor at the site of therapy application*
  • serious blood dyscrasia*
  • blood-clotting disorders*
  • treatment with oral anticoagulants*
  • (*, contraindications of radial extracorporeal shock wave therapy)

结局指标

主要结局

Modified Ashworth Scale (MAS) grade of the plantar flexor muscles

时间窗: Three months after baseline

MAS grade collected on each side at baseline (BL), one month (M1) and three months (M3) after BL. For the patients in the rESWT group, the MAS grade collected before rESWT at BL and after rESWT at M1 and M3. MAS grades are respectively 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) moved in flexion or extension), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved), 3 (considerable increase in muscle tone, passive movement difficult) or 4 (affected part(s) rigid in flexion or extension).

次要结局

  • Gross Motor Function Measure (GMFM)-88(Three months after baseline)
  • Passive range of motion of the foot (pROM)(Three months after baseline)

研究者

申办方类型
Other
责任方
Sponsor

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