A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis)
研究概览
简要总结
The purpose of this project is to investigate if there is a significant difference in active joint range of motion, questionnaire on gait function and health related quality of life between patients randomized to treatment with Botulinum toxin type A and patients randomized to placebo treatment.
详细描述
Cerebral palsy (CP) is a constellation of symptoms and conditions defined as lifelong motor dysfunction resulting rom a non-progressive brain lesion occurring pre-, peri- or postnatal before the second year of life. CP consists of different aspect of motor disorder including spasticity, paresis, incoordination and dystonia
There is scarce knowledge about the association between spasticity, pain and physical function in the adult CP-population, and the systematic follow up of patients with CP typically ends at the age of eighteen. Frequently used intervention in spastic cerebral palsy for children with gait problems are injections with Botulinum toxin type A (Btx-A) in leg and thigh muscles, and three dimensional-gait analysis has become a standard procedure in treatment decision and evaluation.
Botulinum toxin A (Btx- A) is a highly effective treatment in the management of spasticity. The first reported success of use of Btx-A in children with cerebral palsy was made in 1993 by Koman et al. Subsequently, randomized controlled studies on children with spastic type of cerebral palsy has documented that Btx-A is effective and safe in the management of muscle spasticity in children with CP. There is an implicit, and as of yet, unproven assumption that there is no indication for this treatment in the adult CP-population.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral spastic CP
- •Modified Ashworth Scale (MAS) ≥ 2 in ankle- or knee joint muscles.
- •≥ 18 year of age, ≤ 65 year of age
- •Ambulant without walking aids minimum 10 metres in functional equines and/or with pathological knee extension or flexion pattern.
排除标准
- •Cognitive impairment.
- •No spasticity (MAS < 2 )
- •< 18 year of age
- •Not ambulant without walking aids
- •Pregnant or planning pregnancy
- •Btx-A treatment last 6 months
- •Orthopedic surgery lower extremity last 18 months
- •Obvious skeletal/joint deformity where orthopedic surgery is indicated
- •Other diseases which can affect level of function (rheumatoid or neurological )
- •New treatment the past four weeks which affect the musculoskeletal system (pain killers, physical therapy, acupuncture)
研究组 & 干预措施
I
Botox
干预措施: Botulinum toxin type A (Botox) (Drug)
II
干预措施: placebo (saline) (Drug)
结局指标
主要结局
Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis)
时间窗: 8 week
Summary measure of health related quality of life (SF-36)
时间窗: 8 week , 16 week
次要结局
- Stiffness/spasticity according to VAS(8 week, 16 week)
- Questionnaire gait function(8 week, 16 week)
- Spasticity in ankle, knee and hip according to Modified Ashworth Scale(8 week,)
- 3D-gait data (Kinetics,Temporospatial (stride length, velocity)(8 week)
- Global Scale(8 week, 16 week)
- Timed Up and Go(8 week)
- 6 minutes walking test(8 week)
- Registrations of sample characteristics(0 week)
- Registration of adverse reactions(8 week, 16 week)
- Pain according to VAS(8 week, 16 week)