Radial Extracorporeal Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale
研究概览
简要总结
Spasticity is the most common motor disorder in cerebral palsy (CP). The objectives of his therapeutic approach include; reducing pain, ease of use of orthopedic aids, improving posture, minimizing contractures and deformity, and facilitating mobility and dexterity, with the ultimate goal of maximizing the potential of the patient and promoting their independence and quality of life. The approach to spasticity in CP is complex and presents itself as a great challenge for the rehabilitation team. Radial extracorporeal shock wave therapy (rESWT) has been established in recent years as an effective, non-invasive alternative with hardly any side effects (small bruises or discomfort during the application) for the management of spasticity in patients with CP. rESWT is a relatively new therapy in the field of neurology, in 2010 was published the first clinical trial where shock waves were applied for the management of spasticity in patients with CP. Currently, few works have studied the efficacy of rESWT in patients with CP. In all of them, the results demonstrated the treatment's effectiveness in reducing spasticity locally in people with CP up to 3 months after the application. The group most studied muscle has been the Triceps Surae, and there is a great disparity regarding the doses of treatment applied in each study, especially regarding the number of sessions and the time interval between sessions. The most widely used protocol is 3 rESWT sessions with a time interval of 1 week between session; This protocol was established as the most effective in the treatment of trauma pathology. Despite all the variability in the administration of the dose, we have been able to observe that none of them has studied the effect of rESWT by lengthening the time interval between sessions beyond one week to check whether the therapeutic effects on spasticity can be prolonged over time by applying the same dose. Most of the studies conclude that future research should be aimed at studying the most optimal dose of treatment as well as evaluating the long-term results.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CP.
- •With a CP classified as spastic.
- •Spasticity in the Triceps Surae muscle.
- •Who have a Gross Motor Classification (GMFCS) level between l and ll
- •Having signed the informed consent by the participant or your legal guardian
排除标准
- •Have received treatment with shock waves in the Triceps Surae or any other muscle of the lower extremity in the 6 months before the study.
- •Have received treatment with botulinum toxin and/or treatment focal intramuscular injection with phenol or alcohol in the Triceps Surae or some other lower extremity muscle in the 6 months before the study.
- •Patients who have undergone surgery for deformities foot orthotics in the last year.
- •Fixed deformities in the ankle joint.
- •Clinical signs of myopathy and neuropathy.
- •Infection or tumor at the site of application of the therapy*.
- •Severe blood dyscrasia*.
- •Blood coagulation disorders*.
- •Treatment with oral anticoagulants*
- •Contraindications of radial extracorporeal shock wave therapy.
结局指标
主要结局
Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale
时间窗: Base line,3,5,9,12 and 24 weeks
Assess the change in degrees of passive range of motion and the ankle dorsiflexion stretch reflex measured with an inclinometer
Change in goal attainment scale (GAS)
时间窗: Setting of goal(s) at start (base line), assesment al 3,5,9,12 and 24 weeks
Goal attainment scale: Definition of an individual goal at the start. Will be assess the achievement or not of an objective and evaluates the expectations of improvement in each of the goals with a numerical scale from -2 to +2: (-2) Result much lower than expected (-1) Lower than expected result (0) Expected result (+1) Result higher than expected (+2) Result much higher than expected
次要结局
- Pain secondary to spasticity assessed by the visual analog scale(Base line,3,5,9,12 and 24 weeks)
- Adverse effects by Data collection notebook(Base line,3,5,9,12 and 24 weeks)
- Satisfaction with the therapy assessed by the visual analog scale(Base line,3,5,9,12 and 24 weeks)
研究者
Míriam Tur
Principal Investigator
Fundacio Aspace Catalunya