跳至主要内容
临床试验/NCT07485439
NCT07485439Enrolling By Invitation不适用

Self-inspired & Tailored Autism Movement With Phystic App

Linkoeping University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
20
试验地点
1
主要终点
Time on task = time until children loose interest or discontinue the daily exercise session.

研究概览

简要总结

The goal of this clinical trial is to learn if watching instructions for daily exercises with three different contents (the patients themselves, other children, or children dressed as rabbits in addition to their physiotherapist, could increase physical activity among children with autism.

The main questions it aims to answer are: Are children with autism motivated to engage in daily exercise by seeing themselves in a mobile application? Researchers will compare instructions with the children themselves with instructions containing other children and children in rabbit suits.

Parents and their children will use the mobile application once daily for 8 weeks, and 5-10 minutes per day.

Parents will fill out questionnaires before, during and after the 8-week intervention, and write about their experiences in the mobile application 2-3 days per week.

详细描述

BACKGROUND Autism is a collective term for a heterogeneous group of neurological disabilities that mainly manifest themselves in the form of persistent difficulties in social interaction and rigid or repetitive patterns of behavior, activities and interests. The cause of autism is multifactorial and research has shown that there is a complex interaction between genetics and environmental factors when a problem of clinical dimensions is established. Approximately 1 in 50 children is diagnosed with autism, and the problems usually make themselves known at an early age. Autism can often be diagnosed at the age of 2-3 years, although some are diagnosed much later. In many parts of the world, the prevalence of autism has increased, but this is probably due to increased awareness and changes in diagnostic criteria rather than a real increase in incidence.

Children with autism also have a greater degree of intellectual disability, ADHD, anxiety, and epilepsy, which can sometimes complicate both diagnosis and treatment. The great variation in how autism is expressed requires individual strategies in treatment. Over the past decade, research has demonstrated the central role of physical activity in the development of psychological functioning and well-being in children and adolescents in general. Knowledge about how physical activity can improve social, cognitive, and behavioral outcomes in children and adolescents with autism is lacking, and in particular, we know significantly less about young children compared to slightly older children and adolescents.

In two recently published meta-analyses on the importance of physical activity for children with autism, Hassan et al. (2023) and Hynes et al. (2023) highlight group-based exercise as particularly beneficial, but very few studies have examined children in younger age groups. The studies that do exist have generated preliminary evidence for positive effects on attention, memory, problem-solving, and cognitive skills that are linked to motor function. In a 2014 study, Sorensen et al. reported reduced incidence of outbursts and disruptive behavior after physical activity interventions. Similar results were also reported by Liu et al., who noted improved emotion regulation. The link to improved emotion regulation could be a contributing factor to the fact that physical fitness is negatively associated with the risk of developing anxiety and depression.

Despite emerging scientific understanding of the importance of physical exercise for children with autism, there are several important knowledge gaps. Most previous studies have mixed children of different ages, which means that we know little about physical activity in young children with autism. The few studies conducted in young children with autism have not evaluated clearly defined interventions that could be applicable as clinical treatment programs. A prospective study of 100 Swiss children, who were followed from preschool age to grade 2, demonstrated that structured physical activity had a clear positive effect on motor development, while unstructured physical activity lacked such an effect.

A clinically important knowledge gap is the importance of parents for children's activity levels and questions related to how the family can be involved in structured interventions. This aspect is important as physical activity can only lead to positive long-term effects if it is sustained even after a period of supervised training in a clinic. Young children who have just been diagnosed with autism may find it difficult to thrive in the group context that gymnastics, dance, and early introduction to various sports involve. In other words, motivational aspects and evidence-based methods to overcome obstacles to daily movement are as important to study as effects on symptoms, problem behaviors, and motor and cognitive development.

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
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Access to a mobile phone or tablet with a camera and internet at home.
  • Autism diagnosis in the child in question (the patient).
  • Someone in the family knows enough Swedish to understand the information about the study and the content of the mobile app.

排除标准

  • Medical impediment to training with the parents and performing the exercises in the prescribed training sessions.
  • Age >10 years.

结局指标

主要结局

Time on task = time until children loose interest or discontinue the daily exercise session.

时间窗: All days when study participants use the mobile application. .

With assistance from participatnt's parents, the mobile application registers time on task.

次要结局

  • Physical Activity Enjoyment Scale - Short form (PACES-SF)(At baseline and at week 3, 5, 7 and 8.)
  • International Physical Activity Questionnaire (IPAQ)(At baseline and at week 8.)
  • State Anxiety Inventory - Short Form (STAI-SF)(At baseline and at week 8.)
  • Pediatric Insomnia Severity Index (PISI)(At baseline and at week 8.)

研究者

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

Oskar Lundgren, MD, PhD, MSc

Senior Consultant in Pediatrics, Senior Lecturer

Linkoeping University

研究点 (1)

Loading locations...

相似试验