ACTRN12624000579594尚未招募Unknown
RARE FINDS: The effectiveness of an evidence based early motor intervention approach on motor outcomes and goal attainment in young children with rare disease
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- Years 至 5 Years（—）
- 性别
- All
入选标准
- •1) children aged birth to five years old (by the time the study is completed);
- •2) live within a 50-kilometre radius of the Perth central business district (CBD) in Western Australia;
- •3) the child’s primary caregivers must be able to read and understand English without the use of an interpreter;
- •4) children must not currently be receiving therapy services funded by the Australian National Disability Insurance Scheme (NDIS) or other federal or state government funded scheme;
- •5) demonstrate significant developmental delay and/or regression as well as having received a diagnosis of a rare disease (RD), genetic or chromosomal abnormality by a medical practitioner or specialist or evidence of at least one of the risk factors commonly associated with rare disease (RD)
- •Rare disease are defined as those rare diseases with a prevalence rate of less than 1:2000. Risk factors commonly associated with rare disease include the following:
- •- Abnormal brain Magnetic Resonance Imaging (MRI) findings
- •- Abnormal muscle tone including hypertonia, hypotonia, ataxia, dystonia and/or spasticity
- •- Congenital malformations or anomalies including craniofacial anomalies
- •- Diagnosed hearing and/or visual impairment
- •- Feeding difficulty and/or Failure to thrive (FTT)
- •- Hydrocephalus or Microcephaly
- •- Musculoskeletal anomalies i.e. short stature, limb deformity, spinal deformity
- •- One or more birth defect
- •- Proximal and/or distal muscle weakness or muscle atrophy or myopathy
- •- Prenatal Intrauterine Growth Restriction (IUGR)
- •- Systematic illness i.e. cardiovascular problems, metabolic disorders
排除标准
- •1) children with a diagnosis that is not considered a RD i.e. those diseases with a prevalence rate of greater than 1:2000 such as cerebral palsy or down syndrome (this is an important part of our exclusion criteria)
- •2) children who are medically unstable or have been advised against participating in therapy by their primary physician
研究者
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