跳至主要内容
临床试验/NCT04523805
NCT04523805Unknown不适用

Adapted Judo for Children With Autistic Spectrum Disorders

University Ramon Llull2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Change from Pre-intervention in psycho-social and behavioural scores

研究概览

简要总结

The project is aligned with one of the overall: To promote social inclusion and equal opportunities, encouraging participation in sport and physical activity. With this goal in mind, the following specific objectives for this project were established:

  1. To develop an adapted judo programme for children with ASD.
  2. To demonstrate the impact of the participation in adapted judo on the quality of life of people with ASD.
  3. To validate instruments for use among the population with ASD.
  4. To establish a set of coherent pedagogical principles that can be applied throughout the EU to ensure the effectiveness of adapted judo programmes for children with ASD.
  5. To establish a coherent set of pedagogical principles to promote good habits in the participation in judo by children with ASD.
  6. To consolidate and disseminate a systematic approach to adapted judo participation and competition for people with ASD around the EU.

Our hypothesis is that the participants will show improved behaviour after the adapted judo intervention

详细描述

The children were recruited via a number of associations of families with children with ASD and special education schools. All participants had been diagnosed with ASD according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition, (DSM-V). Individuals who had been advised against physical activity for medical reasons were excluded, as were those who had previously taken judo classes. The participants were invited to take part in the study voluntarily, and along with their parents were informed verbally and in writing as to the characteristics of the programme. Parents or legal guardians signed informed consent forms, and the children signed a consent document that explained the objectives and planned activities of the programme. The study was approved by the Research Ethics Committee of (blinded for review). All protocols applied in this research (including the management of the personal data of the participants) complied with the requirements specified in the Declaration of Helsinki of 1975 and its subsequent revisions.

The adapted judo programme is aimed at children of between 8 and 15 years of age who have been diagnosed with ASD and who being introduced to judo. All the project partners will contact institutions and organisations involved in the education of people with ASD in their respective localities and countries. The partners will explain the project and enlist the help of these institutions to recruit participants. All the study participants will be asked to sign an informed consent document that will be drafted in keeping with all applicable research ethics protocols, including a guarantee of the confidentiality of personal data and an assurance that participants can choose to abandon the study at any time.

The judo programme will be carried out over the course of two academic years (2020-21, 2021-22). The first school year will allow for pilot testing of the methods and point toward any necessary adaptations in the assessment techniques used. The design of this first phase will take into account prior experiences, expert input and information gleaned from focus groups in order to arrive at an initial proposal, which will then be subject to modification in accordance with results. The conclusions drawn from this initial experience will form the scientific and pedagogical basis for the definitive version of the programme.

The judo sessions will be offered in a large and well-ventilated space suitable for athletic activity in general and for judo in particular, such that the safety of the participants can be guaranteed. The judo equipment required for this project will include a tatami mat with a minimum surface area of 90 m2, made using high-density cushions that help prevent injuries and ensure that a wide range of activities can be carried out safely. Each participant will be outfitted with a judogui (a traditional uniform consisting of a cotton jacket and trousers and a belt that indicates the participant's level of technical skill).

The sessions will be an hour in length and will be held twice a week. Two instructors will lead each session, and at least four volunteers will have to be present to lend support. The sessions will be divided into three parts in accordance with the physiological principles of exercise: warm-up, main exercise and cool-down. The main content of the sessions will include:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
8 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of ASD.

排除标准

  • Clinical disability for physical activity

结局指标

主要结局

Change from Pre-intervention in psycho-social and behavioural scores

时间窗: Up to 16 weeks

Gilliam Autism Rating Scale-Third Edition (GARS-3) scale (Gilliam, 2014). It includes 56 items describing characteristic behaviours of individuals with autism. The items are divided into six subscales: repetitive behaviours (RB), social interaction (SI), social communication (SC), emotional responses (ER), cognitive style (CS), and maladaptive speech (MS). Each item is scored on a four-point Likert-type scale (0=never observed; to 3=frequently observed), score indicates severity of autism-related behaviours and a lower value represents an improvement. The instrument can be administered by parents or caregivers in 5-10 minutes. It is based on the frequency of occurrence of each item under ordinary circumstances in a six-hour period. The raw score for each subscale was used. ), it should be noted that a low score indicates a decrease in the severity of the characteristics of children with ASD. Change= Pre-intervention (T2- control period) week 8- Post-intervention (T3-judo) week 16

Change from Pre-intervention in motor skills scores

时间窗: Up to 16 weeks

* Battery ALPHA-FITNESS. It obtains the following variables: weight, height, body composition (abdominal perimeter, triceps sheet, subscapular fold), hand strength, leg strength, agility and aerobic endurance. Scale will be reported (min 1-50) higher scores mean a better outcome. * Test of Gross Motor Development (TGMD-3). Evaluates two components: a) Locomotor: Measures gross motor skills that require movements made with a fluid coordination (running, galloping, jumping with one foot, stride, jump with two feet slide). b) Object control: This subtest measures the gross motor skills that require efficiency when throwing, hitting and receiving (hitting a static ball, static jump, reception, shooting, throwing over the head and throwing below the head). Scale will be reported (min 3-36) higher scores mean a better outcome. Change= Pre-intervention (T2- control period) week 8- Post-intervention (T3-judo) week 16

次要结局

  • Change from Baseline in motor skills scores(Up to 8 weeks)
  • Change from Baseline in psycho-social and behavioural scores(Up to 8 weeks)

研究者

发起方
University Ramon Llull
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Morales

Principal Investigator

University Ramon Llull

研究点 (2)

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