Effectiveness of Intermittent Serial Casting on Spastic Wrist Flexion Deformity in Children With Cerebral Palsy Treated By Botulinum Toxin A
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
- 否
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
Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting
干预措施: Botulinum toxin A (Drug)
Casting Group
Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting
干预措施: Occupational Therapy (Other)
Casting Group
Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting
干预措施: Intermittent serial casting (Other)
Control Group
Patients treated by botulinum toxin A and occupational therapy
干预措施: Botulinum toxin A (Drug)
Control Group
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
Nigar Dursun
Head of PMR Department
Kocaeli University
