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临床试验/NCT07456514
NCT07456514已完成不适用

Movement Matters: Feasibility of a Pilot Intervention to Improve Physical Activity and Motor Competence Amongst Children With Intellectual Disabilities

Liverpool John Moores University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年3月16日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
School Eligibility Rate (Screening Log Assessment)

研究概览

简要总结

The goal of this observational study is to find out whether an intervention designed to improve physical activity levels and movement skills is practical and acceptable for children aged 7-11 years with intellectual disabilities and/or autism spectrum disorder.

The intervention will be designed with input from people with lived experience, including professionals working in schools, physical education, sport, health services, and charities, as well as parents and families. The study will explore whether this type of intervention can be realistically delivered in special educational needs schools as part of their usual day-to-day activities.

The main question the study aims to answer is:

• Is an intervention to improve physical activity and motor skills feasible and acceptable for special educational needs schools?

Participating schools will implement the intervention for six weeks. Several outcomes related to feasibility and acceptability will be measured to understand how well the intervention works in a school setting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 7 to 11 years
  • Special Educational Needs and Disability (SEND) statement indicating a primary diagnosis of intellectual disability and/or Autism Spectrum Disorder
  • Independently ambulatory (able to walk without physical assistance) to allow completion of the motor skill testing protocol

排除标准

  • Children younger than 7 years or older than 11 years
  • No Special Educational Needs and Disability (SEND) statement indicating a primary diagnosis of intellectual disability or Autism Spectrum Disorder
  • Not independently ambulatory and therefore unable to complete the motor skill testing protocol

结局指标

主要结局

School Eligibility Rate (Screening Log Assessment)

时间窗: Baseline

Percentage of all SEND schools in the target area that meet predefined inclusion criteria, assessed using a school eligibility screening log.

Participant Recruitment Rate (Consent Form Return Log)

时间窗: Baseline

Percentage of eligible children who return completed parent/carer consent forms, recorded using a consent tracking log.

Completion Rate of Motor Competence (BOT-2), Physical Activity (Accelerometry), and Anthropometric (Stature and Body Mass) Measures

时间窗: Baseline to the end of intervention at 6 weeks

Percentage of recruited participants who complete all baseline and follow-up assessments using the Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2), Accelerometer (ActiGraph GT3X worn on the non dominant wrist for 7-days), stature measured to the nearest 0.1cm and body mass to the nearest 0.1 kg.

Loss to Follow-Up Rate (Child-Level Outcome Assessment Completion Log)

时间窗: Baseline to the end of intervention at 6 weeks

Percentage of recruited participants who do not complete any follow-up assessments, recorded using the study assessment tracking log.

Intervention Dose Delivered (Teacher Implementation Log)

时间窗: Baseline to the end of intervention at 6 weeks

Adherence to the Movement Matters intervention measured using a fidelity checklist completed by teachers

Teacher and Coach Acceptability (Post-Training Acceptability Questionnaire)

时间窗: Baseline to the end of intervention at 6 weeks

Study-specific post-training acceptability questionnaire consisting of 5-point Likert scale items assessing satisfaction, perceived usefulness, and appropriateness of the training.

Intervention Acceptability (Teacher Post-Intervention Acceptability Questionnaire)

时间窗: Baseline to the end of intervention at 6 weeks

Teacher satisfaction with the intervention measured using a structured post-intervention acceptability questionnaire including 5-point Likert scale items assessing overall satisfaction (not at all satisfied to very satisfied), perceived ease of use, and perceived burden (strongly disagree to strongly agree), as well as open-ended qualitative feedback questions.

次要结局

  • Change in Physical Activity Levels (Measured by accelerometry)(Baseline to the end of intervention at 6 weeks)
  • Change in Motor Competence (Measured by BOT-2)(Baseline to the end of intervention at 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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