Action Observation Training [AOT] to Improve Upper Limb Function in Infants After Unilateral Brain Lesion - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Feasibility of and adherence to Action Observation Training in infants measured by an intervention diary
研究概览
简要总结
The study examines whether infants with a perinatal unilateral brain lesion can perform an "Action Observation Training" [AOT] at the age of 9-12 months . AOT is the targeted and concentrated observation of movements and actions to learn new motor skills. In adults with hemiplegia after a stroke and in older children with hemiplegia, AOT can lead to an improvement in the functions of the affected hand/arm. Infants with early unilateral brain damage are at increased risk of developing a hemiplegia and thus impaired upper limb function. There is little known about treatment options to promote arm and hand skills in early childhood and their effectiveness. In particular, there is a lack of knowledge whether AOT could also be used in infants. It is known that even in infants at an early age brain activity can be measured while they are observing movements and infants learn a lot about observing and imitating.
Knowledge about the measurement of manual skills is also reduced. So far, tests have been used to observe and evaluate how infants use their hands when playing (e.g. Mini-Assisting Hand Assessment). The aim of this study is to investigate whether measurements with motion sensors can also be used in infants.
In the pre-post study, about 5 to 10 toddlers will be examined. During four weeks, the parents should give the child 20 minutes of AOT per day at home. A therapy diary will be completed for this purpose. During six weeks, the parents will use movement sensors on two days a week for the upper limb of the infants. Finally, three questionnaires about the AOT and the motion sensors will be completed by the parents.
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
- 9 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature and term-born infants aged 9-12 months
- •Perinatal unilateral brain damage due to cerebral hemorrhage or stroke
- •Informed consent to study participation by the parents or legal representative
排除标准
- •Infants with impaired vision
- •Other diagnoses than early childhood brain damage affecting the functions of the upper extremities (e.g. plexus palsy)
- •Infants who participate in other studies of upper extremity interventions
- •Parents do not understand the study and the intervention due to foreign language skills
结局指标
主要结局
Feasibility of and adherence to Action Observation Training in infants measured by an intervention diary
时间窗: Four weeks during the Intervention
To assess the adherence of the intervention the parents fill out a diary. In addition to the training duration in minutes per day, the number of training sequences, the persons involved, the content of the AOT and the attention, motivation and imitation behaviour of the child should also be documented. The parents are asked to write down further comments on the form which may contribute to a better understanding.
次要结局
- Accelerometry(The infants wear the accelerometers two days a week during the study duration of six weeks)
- Action Observation Training Questionnaire Part II acceptance(Posttest, expected to be an average of 10 minutes)
- Hand Assessment for Infants [HAI](Pre- and Posttest, expected to be an average of 15 minutes)
- Action Observation Training Questionnaire Part I feasibility(Posttest, expected to be an average of 10 minutes)
- Mini-Assisting Hand Assessment [Mini-AHA](Pre- and Posttest, expected to be an average of 15 minutes)
- Questionnaire Accelerometer(Posttest, expected to be an average of 5 minutes)
- System Usability Scale [SUS](Posttest, expected to be an average of 5 minutes)