The Role of Physiotherapy in the Mental Health of Children and Adolescents With Neurodevelopmental Disorders: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Change in Stress Levels (DASS-21 Stress Subscale)
研究概览
简要总结
This study investigates whether a structured physiotherapy program can help reduce symptoms of stress, anxiety, and depression in children and adolescents diagnosed with Autism Spectrum Disorder (ASD) or Attention-Deficit/Hyperactivity Disorder (ADHD). ASD and ADHD are neurodevelopmental conditions often associated with emotional and behavioral challenges, including elevated levels of psychological distress.
The physiotherapy intervention includes techniques such as diaphragmatic breathing, acupressure, relaxation exercises, proprioceptive activities, and therapeutic positions designed to support emotional regulation. Children aged 6-18 years are randomly assigned to either an intervention group receiving the physiotherapy program or a control group receiving usual care.
The purpose of the study is to evaluate whether this physiotherapy protocol can positively influence emotional well-being and behavioral indicators related to ASD and ADHD. Outcomes are assessed using validated questionnaires measuring stress, anxiety, depression, and disorder-related behavioral characteristics before and after the intervention.
详细描述
This study examines the implementation of a structured physiotherapy program designed for children and adolescents diagnosed with Autism Spectrum Disorder (ASD) or Attention-Deficit/Hyperactivity Disorder (ADHD). The intervention includes breathing exercises, relaxation techniques, proprioceptive activities, and therapeutic postures aimed at supporting emotional regulation and reducing psychological distress.
Participants aged 6 to 18 years are randomly assigned to either an intervention group receiving the physiotherapy program or a control group receiving usual care. Standardized assessment tools are used to measure stress, anxiety, depression, and behavioral characteristics related to ASD and ADHD. The study follows a parallel-group randomized design and aims to evaluate the feasibility and potential therapeutic impact of physiotherapy-based approaches in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor was blinded to group assignment to minimize assessment bias.
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Diagnosis of Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD) by a qualified clinician.
- •Age between 6 and 18 years.
- •Ability to participate in structured physiotherapy sessions.
- •Stable medication regimen (if applicable) for at least 4 weeks prior to study entry.
- •Parent/guardian consent and child assent (where applicable).
- •Ability of parents/guardians to comply with study procedures and assessments.
排除标准
- •Severe intellectual disability that prevents participation in physiotherapy activities.
- •Uncontrolled epilepsy or other neurological disorders that pose safety risks.
- •Severe sensory or motor impairments preventing safe exercise participation.
- •Participation in another clinical study within the last 3 months.
- •Any acute medical condition deemed unsafe for physical activity.
- •Behavioral issues that prevent structured participation (e.g., aggressive behavior).
研究组 & 干预措施
Physiotherapy Intervention Group
Participants receive a structured physiotherapy program designed to improve emotional regulation, reduce anxiety symptoms, and enhance overall mental health. The program includes sensorimotor exercises, coordination training, postural activities, and structured physical activity tailored to children and adolescents with ASD or ADHD.
干预措施: Structured Physiotherapy Program (Behavioral)
Comparator Group
Participants do not receive physiotherapy during the study period but continue their usual daily routines. After study completion, they are offered the physiotherapy program.
结局指标
主要结局
Change in Stress Levels (DASS-21 Stress Subscale)
时间窗: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)
Stress levels assessed using the DASS-21 Stress Subscale (score range 0-42). Higher scores indicate higher stress. The outcome will be analyzed as the change in score from baseline to post-intervention.
Change in Depression Levels (DASS-21 Depression Subscale)
时间窗: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)
Depression levels assessed using the DASS-21 Depression Subscale (score range 0-42). Higher scores indicate higher depressive symptoms. The outcome will be analyzed as the change in score from baseline to post-intervention.
Change in Anxiety Levels (DASS-21 Anxiety Subscale)
时间窗: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)
Stress/anxiety levels assessed using the DASS-21 Anxiety Subscale (score range 0-42). Higher scores indicate greater anxiety symptoms. The outcome will be analyzed as the change in score from baseline to post-intervention.
次要结局
- Change in ADHD-Related Behavioral Indicators (ADHD Parent Questionnaire Score)(Baseline and post-intervention (after 10 sessions - approximately 5 weeks))
- Change in Autism-Related Behavioral Indicators (CAST Score)(Baseline and post-intervention (after 10 sessions - approximately 5 weeks))
研究者
Marianna Stavropoulou
Principal Investigator
International Hellenic University