The Evaluation of Effects of Botulinum Toxin Injection on Lower Extremity Somatosensory Impairment and Postural Control in Children With Hemiplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test of NeuroCom Balance Master
研究概览
简要总结
In this study, the investigators aimed to investigate the effects of botulinum neurotoxin type A (BoNT-A) injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic cerebral palsy who are ambulatory without an assistive device in daily life.
详细描述
Cerebral palsy (CP) refers to a group of movement and posture disorders that limit activity and participation, that are attributed to non-progressive disturbances in the developing fetus or infant brain. One of the main clinical findings of CP is postural control disorder. Many concomitant impairments such as joint range of motion limitations, spasticity, contractures, sensory deficits and loss of selective motor control contribute to postural control disorder.
One of the most common causes of motor dysfunction in children with CP is the presence of spasticity. Spasticity in the ankle plantar flexor muscles and weakness in the dorsiflexor muscles are the main factors that cause gait disturbance. Thus, impairments in gait function cause limitation of postural stability. Although there are many methods in spasticity management, BoNT-A injections have been used effectively and safely for many years, especially in reducing ankle plantar flexor spasticity. There are limited number of studies in the literature investigating the effect of BoNT-A injection on postural control in children with spastic CP, and only one study included children with spastic hemiplegic (unilateral) CP and it was clearly highlighted that new studies are needed in this area.
The reclassification of CP acknowledges the contribution of impaired sensation in motor performance. Although it has been shown that somatosensory deficits in the lower extremities of children with spastic CP can negatively affect gait and balance, the effect of spasticity in the ankle has not been evaluated.
In this study, the investigators aimed to investigate the effects of BoNT injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic CP who are ambulatory without an assistive device in daily life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with hemiplegic cerebral palsy
- •Age between 5-13 years
- •MAS ≥ 2 spasticity in the affected ankle
- •Gross Motor Function Classification System (GMFCS) level I-II
- •Able to understand given commands
- •Sufficient cooperation to understand instructions and participate evaluations
- •Giving an informed consent
- •Botulinum toxin A injection decision made by an experienced Physiatrist
排除标准
- •Visual, vestibular and cognitive deficits
- •Botulinum toxin A treatment within 6 months or having undergone an orthopaedic surgery 1 year prior to inclusion in the study
- •Presence of fixed contracture or joint instability in the affected ankle
- •Severe scoliosis (Cobb angle >40°)
- •Uncontrolled epilepsy
- •Having undergone selective dorsal rhizotomy
研究组 & 干预措施
Botulinum toxin-A
Botulinum toxin-A (Onabotulinum toxin type-A) injection with electrical stimulation guidance will be administered to spastic ankle plantar flexor muscles. After the injection, the patients will be included in the comprehensive physiotherapy program.
干预措施: Botulinum toxin type-A (Onabotulinum toxin type-A) (Drug)
Botulinum toxin-A
Botulinum toxin-A (Onabotulinum toxin type-A) injection with electrical stimulation guidance will be administered to spastic ankle plantar flexor muscles. After the injection, the patients will be included in the comprehensive physiotherapy program.
干预措施: Physical Therapy (Other)
结局指标
主要结局
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test of NeuroCom Balance Master
时间窗: 3rd month after intervention (T2)
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.
Light touch pressure treshold
时间窗: 3rd month after intervention (T2)
Light touch pressure (tactile) sensation will be assessed by using Semmes-Weinstein Monofilaments kit (Baseline, White Plains, New York, NY,USA) at the first and fifth metatarsal heads and heel of the plantar side of each foot. The light touch pressure threshold will be defined as the thinner monofilament value the participant correctly identified twice out of three trials for each application site. Higher scores mean worse tactile sensation.
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) of NeuroCom Balance Master
时间窗: before intervention (T0)
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.
次要结局
- Two-point discrimination(3rd month after intervention (T2))
- Modified Ashworth Scale (MAS)(3rd month after intervention (T2))
- Modified Tardieu Scale (MTS)(3rd month after intervention (T2))
- Selective Control Assessment of the Lower Extremity (SCALE)(3rd month after intervention (T2))
- Sit to Stand (STS) test of Neurocom Balance Master(3rd month after intervention (T2))
- Step&Quick Turn (SQT) test of Neurocom Balance Master(3rd month after intervention (T2))
- Timed Up and Go (TUG) test(3rd month after intervention (T2))