Comparison of Osteopathic Treatment Versus Simulation on Motor Development of Hypotonic Infants.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Motor development on the Denver II scale
研究概览
简要总结
Interventional study involving the human at risk and minimal constraint (RIPH2), randomized single-blind comparing the impact of osteopathic treatment on the axial tone of the hypotonic infant versus simulation
详细描述
Children referred to the "Center Broussais" clinic for hypotonia are evaluated in terms of psychomotor development by a pediatrician competent in neuro-pediatrics. It is a cabinet for the care of children from 0 to 16 years.
Osteopaths and pediatricians work together in this office of which 50% are children with neurological disorders.
If osteopathic care is indicated, and for children with inclusion / non-inclusion criteria, the study will be offered to parents. In case of parental acceptance, children will be randomized in single blind to receive either an osteopathic treatment (osteo group) or a simulation (simulation group). Neither the parents nor the pediatrician will know the randomization group.
The osteopathic treatment or simulation will be performed in a standardized way according to a previously established protocol.
In both groups, a neurological evaluation of the axial tone will be performed by a pediatrician before randomization, at the end of the first consultation and at the end of the 3rd consultation, ie 3 consultations by a pediatrician.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
simulated osteopathic treatment
入排标准
- 年龄范围
- 8 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 8 months-24 months corrected age Axial hypotonia in the neurological examination
- •Age (age corrected for prematurity) of motor development evaluated on the Denver II scale below chronological age
- •Proposal for osteopathic treatment by the pediatrician or treating physician
排除标准
- •• Fever, shock or recent fall (face, skull, spine) not medically investigated, persistent cyanosis, bulging or depressed fontanel, cervical stiffness, fever
- •Neuromuscular diseases without axial hypotonia
- •Not affiliated to a social security scheme
- •Refusal to participate in the study by parents
研究组 & 干预措施
simulated osteopathic treatment
A simulated ostepathic treatment will be realised by osteopath
干预措施: simulated osteopathic treatment (Other)
Osteopatic treatment
An osteopatic treatment will be realised by osteopath
干预措施: ostheopathy (Other)
结局指标
主要结局
Motor development on the Denver II scale
时间窗: at month 6
Comparison of the difference between chronological age (in corrected age) and motor development age on the Denver II motor scale in the 2 groups after 3 osteopathy consultations or simulation
次要结局
- Motor development on the Denver II scale(at month 4)
- Satisfaction visual scale (from 0 to 10)(at month 6)