Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Children With Cerebral Palsy, Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Change of muscle spasticity after the intervention
研究概览
简要总结
The aim of the study is to evaluate a short term influence of the Spinal Manipulation (SM) on the wrist muscles spasticity and manual dexterity in children with spastic Cerebral Palsy.
Effect of SM and imitation of the SM has to be compared in the double-blinded randomized clinical trial.
详细描述
Muscle spasticity is an important clinical syndrome of Cerebral Palsy (CP) resulting from upper motor neuron lesion, and its reduction is a significant therapeutic target for optimizing motor performance.
Investigator's recent study describes decrease in spasticity after SM in a group of children with CP. But that case series has no control group and the sample size was small so it does not prove the influence of the SM on the muscle spasticity.
The purpose of the present study is to evaluate influence of the SM on muscle spasticity and on manual dexterity of the child with CP in a double-blind randomized clinical trial with two arms: SM (experimental group) and imitation of SM (control group).
Children admitted to the International Clinic of Rehabilitation are selected according to inclusion-exclusion criteria and invited to participate. After getting the permission the baseline assessment is performed.
Patients are allocated to the experimental or control group using stratified randomization. Medical doctor certified in Manual Therapy performs the intervention (SM in the experimental group and imitation in the control group) and in 15 minutes the second assessment is performed. Investigators, children and parents are blinded to group allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spastic uni-, bilateral Cerebral Palsy
- •Manual Ability classification level (MACS) - I-III level
- •Modified Ashworth scale (MAS) grade 1-3 in wrist or fingers flexors
排除标准
- •Dyskinetic or ataxic syndrome
- •Less than 40 degrees of passive wrist extension with fingers extended
- •Botox injections in hand muscles during last year or recent antispastic drugs
- •Fracture in hand or forearm less than 6 month prior to examination
- •Uncooperative behavior, inability to understand and comply with instructions
- •Severe pain preventing the child from being able to complete examinations
研究组 & 干预措施
Spinal manipulation
Spinal manipulation
干预措施: Spinal manipulation (Procedure)
Imitation of the spinal manipulation
Imitation of the spinal manipulation
干预措施: Imitation of the spinal manipulation (Procedure)
结局指标
主要结局
Change of muscle spasticity after the intervention
时间窗: Baseline assesment and 15 min after intervention
Quantitative, instrumental spasticity measurement is preformed using the Neuroflexor device. It is measuring resistance to passive movements of the wrist performed with different speed and calculates components of muscle tone, separating spasticity as reflex phenomenon from resistance due to secondary changes of the muscles and tendons.
次要结局
- Change of manual dexterity after the intervention(Baseline assesment and 15 min after intervention)
研究者
Oleh Kachmar
Head of Innovative Technologies Department
International Clinic of Rehabilitation, Ukraine