Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Measurement of oculomotricity with eye-tracking system (visual orientation and control)
研究概览
简要总结
This research is a case-control study aiming to characterize motor peculiarities (objective quantitative and qualitative measures) and its psycho-physiological correlates of children with ASD.
详细描述
The main objective is to measure jointly and in an automated and standardized manner the performance and motor patterns within the framework of tasks measuring the performance and patterns of general motor skills (postures, walking, coordination overall), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).
The secondary objective is to investigate the relationships between motor difficulties and cognitive and social disorders found in children with ASD.
- Compare the motor performance data in the 3 major motor domains with each other (overall, fine and oculomotor);
- Evaluate intergroup differences based on clinical characteristics (ADOS-2, ADI-R, CARS 2 scores), age, IQ, socio-communication profile score (SRS-2) and presence comorbidities (TADH, TDC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants :
- •Be between 6 and 11 years old
- •Mastery of the French language
- •Be affiliated with a Social Security scheme or benefit from affiliation by a third person
- •Both parents (or the holder of legal authority) have read, understood and signed the study consent
- •Be affiliated with social security
- •Participants with ASD should also verify the following inclusion criteria:
- •Being diagnosed with ASD (DSM-V)
排除标准
- •All participants :
- •Refusal to participate in the research on the part of the participant and / or holders of parental authority.
- •Be a person benefiting from enhanced protection, namely : persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment.
- •Have uncorrected visual or hearing problems
- •To have concomitant psychotropic drug treatments not stabilized, initiated in the last 2 months: antipsychotics, mood stabilizers, anti-epileptics, psychostimulants, antidepressants.
- •Have a motor handicap of the upper or lower limbs, fitted or not.
- •Have diagnosed neurological or psychiatric disorders, present a general or metabolic pathology having a known impact on the child's motor skills (eg: Epilepsy, Tics and Gilles de la Tourette Syndrome, Intellectual Deficiency, Neuromuscular Syndrome, Metabolic Neurological Syndrome , neoplasms)
- •Suspicion of low intellectual efficiency if at least one of the two subtests (Similarities or Matrices) of WISC V (retrieved from the medical file if the TSA participant) presents a result (standard score) strictly lower than
- •Participants without ASD :
- •Participant with ADHD (Attention Deficit Disorder with or without Hyperactivity) or CDD (Developmental Coordination Disorder)
研究组 & 干预措施
Epidemiology
Recording of participant's performance during eye, fine motor and gross motor tests Passing self and hetero questionnaires.
干预措施: Testing of general motor skills, fine motor skills and occulomotricity (Behavioral)
Epidemiology
Recording of participant's performance during eye, fine motor and gross motor tests Passing self and hetero questionnaires.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Measurement of oculomotricity with eye-tracking system (visual orientation and control)
时间窗: At 3 month
Jointly and in an automated and standardized manner, motor patterns in the context of tasks measuring the performance and patterns of general motor skills (postures, walking, overall coordination), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).
Measurement performance of fine motor skills (graphics, pointing task)
时间窗: At 3 month
Jointly and in an automated and standardized manner, measure performance in the context of tasks measuring the performance and patterns of general motor skills (postures, walking, overall coordination), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).
Measurement performance of general motor skills with biomechanical analysis
时间窗: At 3 month
Jointly and in an automated and standardized manner, measure motor patterns in the context of tasks measuring the performance and patterns of general motor skills (postures, walking, overall coordination), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).
次要结局
- Score of socio-communicative skills as assessed using Social Responsiveness Scale(At visit 1 and visit 2, an average of 3 months)
- Motor performance : success, error rate (%)(At visit 1 and visit 2, an average of 3 months)
- Motor performance : task duration (ms), reaction time (ms) and latency (ms)(At visit 1 and visit 2, an average of 3 months)
- IQ as assessed using WISC IV(At visit 1 and visit 2, an average of 3 months)
- ADHD as assessed using Conners-3(At visit 1 and visit 2, an average of 3 months)
- Developmental Coordination Disorder as assessed using Developmental Coordination Disorder Questionnaire(At visit 1 and visit 2, an average of 3 months)
- ASD Clinical Assessment as assessed using Childhood Autism Rating Scale(At visit 1 and visit 2, an average of 3 months)