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临床试验/NCT06128616
NCT06128616尚未招募3 期

Efficacy of Extracorporeal Shock Wave Therapy Integrated to Combined Treatment of Botulinum Toxin A and Serial Casting in Children With Cerebral Palsy

Kocaeli University0 个研究点目标入组 40 人开始时间: 2023年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
40
主要终点
Mean change from baseline passive range of movement

研究概览

简要总结

Spastic plantar and palmar flexion deformities are very common in children with cerebral palsy (CP). These deformities usually involve spasticity of the plantar or palmar muscle complexes, weakness of the antagonist dorsiflexor muscles of the ankle or wrist, and also involve soft tissue/muscle contractures and require a multimodal treatment approach. Physical therapy (PT), occupational therapy (OT), serial casting (SC), and botulinum toxin A (BoNT-A) injections had shown positive results in both of these deformities. Recent systematic reviews and meta-analyses showed that extracorporeal shock wave therapy (ESWT) is effective in reducing spasticity, pain intensity, and increasing range of motion and motor function when combined with PT or BoNT-A injections in neurological conditions like stroke, CP, multiple sclerosis. ESWT can be a complimentary therapy to obtain an earlier efficacy, better efficacy, a sustained effect for a longer period, and less adverse events. The objective of this study was to show the effects of ESWT when combined with intermittent SC, BoNT-A injections and PT or OT on spasticity, passive range of motion (pROM) of children with CP having spastic equinus foot deformity or wrist palmar flexion deformity.

详细描述

Spasticity is one of the most common motor disorder which may slowly cause soft tissue contractures in children with CP. Spastic plantar and palmar flexion deformities are very common in children with CP. These deformities usually involve spasticity of the plantar or palmar muscle complexes, weakness of the antagonist dorsiflexor muscles of the ankle or wrist, and also involve soft tissue/muscle contractures. PT, OT, SC, and BoNT-A injections had shown positive results in both of these deformities. Skin irritation or breakdown, painful episodes, oedema, tendonitis, weakness, stiffness are some of the side effects reported after SC. Moreover casting especially when prolonged might complicate activities of daily living for instance by increasing the risk of falls or causing problems in bathing. Recent evidence from literature favors early, goal oriented, activity based, intensive, repetitive motor trainings in enriched environments to optimize neuroplasticity in children with CP. Prolonged SC might also interfere with these activity based, intensive rehabilitation options for upper extremity. In order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed and used both for children with CP presenting equines foot deformity or palmar flexion deformity. Combined management of intermittent SC, and BoNT-A injections had shown better results compared to either treatment alone in both of these deformities. Recent systematic reviews and meta-analyses showed that ESWT is effective in reducing spasticity, pain intensity, and increasing range of motion and motor function when combined with PT or BoNT-A injections in neurological conditions like stroke, CP, multiple sclerosis. ESWT can be a complementary therapy to obtain an earlier efficacy, better efficacy, a sustained effect for a longer period, and less adverse events.

The objective of this study was to show the effects of ESWT when combined with intermittent SC, BoNT-A injections and PT or OT on spasticity, passive range of motion (pROM) of children with CP having spastic equinus foot deformity or wrist palmar flexion deformity.

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
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Having a diagnosis of CP according to Rosenbaum criteria, presenting plantar or palmar flexion deformity, having a Modified Ashworth Scale score of 3 in plantar or palmar flexor muscle groups, being scheduled for BoNT-A treatment, intermittent serial casting and physical or occupational therapy

排除标准

  • Having cognitive dysfunction, having a history of orthopedic surgery, presenting significant dystonia, having vascular disease, fracture, or dislocation

研究组 & 干预措施

ESWT Group

Experimental

Patients treated by BoNT-A, intermittent SC and ESWT, whom received either PT or OT

干预措施: Physical Therapy (Behavioral)

ESWT Group

Experimental

Patients treated by BoNT-A, intermittent SC and ESWT, whom received either PT or OT

干预措施: ESWT (Device)

ESWT Group

Experimental

Patients treated by BoNT-A, intermittent SC and ESWT, whom received either PT or OT

干预措施: Botulinum Toxin Type A (Drug)

ESWT Group

Experimental

Patients treated by BoNT-A, intermittent SC and ESWT, whom received either PT or OT

干预措施: Serial Casting (Other)

ESWT Group

Experimental

Patients treated by BoNT-A, intermittent SC and ESWT, whom received either PT or OT

干预措施: Occupational Therapy (Behavioral)

Control Group

Active Comparator

Patients treated by BoNT-A, and intermittent SC, whom received either PT or OT

干预措施: Botulinum Toxin Type A (Drug)

Control Group

Active Comparator

Patients treated by BoNT-A, and intermittent SC, whom received either PT or OT

干预措施: Serial Casting (Other)

Control Group

Active Comparator

Patients treated by BoNT-A, and intermittent SC, whom received either PT or OT

干预措施: Physical Therapy (Behavioral)

Control Group

Active Comparator

Patients treated by BoNT-A, and intermittent SC, whom received either PT or OT

干预措施: Occupational Therapy (Behavioral)

结局指标

主要结局

Mean change from baseline passive range of movement

时间窗: Post-treatment weeks 12-20

Soft tissue contracture measurement

Mean change from baseline Tardieu XV3 angle

时间窗: Post-treatment weeks 4-6

Spasticity measurement

次要结局

  • Faces Pain Scale(Post-treatment weeks 4-12-20)
  • Goal Attainment Scale-Light(Post-treatment weeks 4-12-20)

研究者

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

Nigar Dursun

Professor

Kocaeli University

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