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临床试验/NCT03306212
NCT03306212已完成3 期

Effectiveness of Intermittent Serial Casting on Spastic Wrist Flexion Deformity in Children With Cerebral Palsy Treated By Botulinum Toxin A

Kocaeli University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
34
试验地点
1
主要终点
Mean change from baseline Passive ROM

研究概览

简要总结

Spastic wrist flexion deformity is a very common problem in children with CP. Although serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of children with CP, there is limited data on SC in the upper extremity.

In this prospective, randomized, controlled clinical trial in order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed. The objective of this study was to show the effects of intermittent SC when combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having spastic wrist flexion deformity.

详细描述

Spasticity is not only the most common motor disorder but also the main cause of slowly developing secondary problems like contractures in children with cerebral palsy (CP). Spastic wrist flexion deformity is a very common problem in children with CP and can be primarily due to spasticity of the palmar muscle complex, can be exacerbated by the weakness of the antagonist dorsiflexor muscles and can involve soft tissue and joint contractures. Although serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of children with CP, there is limited data on SC in the upper extremity. Skin irritation or breakdown, painful epizodes, 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 serial casting might also interfere with these activity based, intensive rehabilitation options for upper extremity.

In this prospective, randomized, controlled clinical trial in order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed. The objective of this study was to show the effects of intermittent SC when combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having spastic wrist 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 (Investigator)

入排标准

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

入选标准

  • having a diagnosis of CP according to Rosenbaum criteria,
  • having a unilateral spastic palmar flexion deformity of wrist joint,
  • having a Modified Ashworth Scale (MAS) score of 3 in the palmar flexor muscle complex,
  • being scheduled for BoNT-A treatment to upper extremity including palmar flexor muscle group.

排除标准

  • having cognitive dysfunction,
  • having a history of orthopedic surgery to upper extremity,
  • having significant dystonia,
  • having infection skin breakdown,
  • having vascular disease,
  • having fracture or dislocation.

研究组 & 干预措施

Casting Group

Experimental

Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting

干预措施: Botulinum toxin A (Drug)

Casting Group

Experimental

Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting

干预措施: Occupational Therapy (Other)

Casting Group

Experimental

Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting

干预措施: Intermittent serial casting (Other)

Control Group

Active Comparator

Patients treated by botulinum toxin A and occupational therapy

干预措施: Botulinum toxin A (Drug)

Control Group

Active Comparator

Patients treated by botulinum toxin A and occupational therapy

干预措施: Occupational Therapy (Other)

结局指标

主要结局

Mean change from baseline Passive ROM

时间窗: 12 weeks

Range of motion measurement

Mean change from baseline MAS score

时间窗: 12 weeks

Tone measurement

次要结局

  • Mean change from XV3 angle of Tardieu scale(12 weeks)

研究者

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

Nigar Dursun

Head of PMR Department

Kocaeli University

研究点 (1)

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