The Effects of Botulinum Toxin Type a Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Modified Aschworth Scale
研究概览
简要总结
This study aimed to check and compare the effects of botulinum toxin injection combined with shock wave therapy versus botulinum toxin injection only for lower extremity spasticity in children with cerebral palsy
详细描述
20 pediatric patients diagnosed with cerebral palsy who received botulinum toxin type A injection for lower extremity spasticity were divided into two groups. The first group will receive only conventional treatment after the injection, while the second group will receive extracorporeal shockwave therapy for injected muscles. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection. Patients will be compared in terms of MAS scores, MTS scores, passive joint range of motion, modified timed up and go test, pain scores, (faces pain scale-revised) and Goal Attainment Scaling scores. Patients will be evaluated 1 week, 1 month and 3 months after the injection with pre-injection data.
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)
盲法说明
Outcomes Assessor were blinded to patients who received shockwave therapy and who did not received.
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cerebral palsy.
- •Spasticity in at least one of the lower extremity muscle groups.
- •No contraindications to shockwave therapy.
- •Applied Botulinum Toxin Type A injection for at least one spastic muscle of lower extremity.
- •Agreed to participate to study (patient/primary caregiver)
排除标准
- •Surgery history within the last year of the muscle to be injected and treated
- •Having uncontrolled epilepsy.
- •Having infection
- •Coagulopathy
结局指标
主要结局
Modified Aschworth Scale
时间窗: 3 months (before injection, first week, first month and third month after injection.)
Scoring system used to evaluate spasticity. Spasticity scored as 0, 1, 1+, 2, 3, 4.
Modified Tradiue Scale
时间窗: 3 months (before injection, first week, first month and third month after injection.)
Scoring system used to evaluate spasticity. Spasticity scored as 0,1,2,3,4.
Modified Timed Up and Go Test
时间窗: 3 months (before injection, first week, first month and third month after injection.
The test for evaluate the functionality of pediatric patients with cerebral palsy. Only one chair and a surface for the patient to walk three meters are required. The time it takes for the patient to get up from the chair, walk the specified distance and sit back in the chair is recorded.
Facies Pain Scale Revised
时间窗: 3 months (before injection, first week, first month and third month after injection.)
The scale for evaluate the pain level of pediatric patients. Chosen faces are scored 0, 2, 4, 6, 8, or 10, counting left to right, so "0" equals "No pain" and "10" equals "Very much pain."
Passive Range of Motion
时间窗: 3 months (before injection, first week, first month and third month after injection.)
Goniometric measurement of the range of motion of the joint of the injected muscle
Goal Attaintment Scale
时间窗: 3 months (before injection, first week, first month and third month after injection.)
The method of scoring the extent to which patient's individual goals are achieved in the course of intervention. GAS comprises of goals divided into a 5-point scale from -2 to +2. Achievement of goal = 0 Achieved somewhat more than expected outcome = +1 Achievement of much more than expected goal = +2 Achievement of somewhat less than expected goal = -1 Achievement of much less than expected goal = -2
次要结局
未报告次要终点
研究者
Bilinç Doğruöz Karatekin
Bilinc Dugruoz Karatekin, M.D., Department of Physical Medicine and Rehabilitation
Istanbul Medeniyet University