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Physiotherapy for Improving Mental Health in Children and Adolescents With ASD and ADHD

The Role of Physiotherapy in the Mental Health of Children and Adolescents With Neurodevelopmental Disorders: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07231354
Enrollment
117
Registered
2025-11-17
Start date
2022-06-28
Completion date
2023-07-15
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Neurodevelopmental Disorders

Keywords

Physiotherapy, Mental Health, Children, Adolescents, Exercise Therapy, Rehabilitation

Brief summary

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.

Detailed description

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.

Interventions

A structured multimodal physiotherapy program including sensorimotor integration exercises, balance and coordination training, postural control activities, therapeutic physical activity, breathing regulation techniques, and proprioceptive stimulation. The intervention is tailored to children and adolescents with ASD or ADHD and aims to improve emotional regulation, reduce anxiety, enhance behavioral self-control, and promote overall mental health.

Sponsors

International Hellenic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcomes assessor was blinded to group assignment to minimize assessment bias.

Intervention model description

Two-arm parallel-group randomized controlled design.

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Stress Levels (DASS-21 Stress Subscale)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 Anxiety Levels (DASS-21 Anxiety Subscale)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.
Change in Depression Levels (DASS-21 Depression Subscale)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.

Secondary

MeasureTime frameDescription
Change in Autism-Related Behavioral Indicators (CAST Score)Baseline and post-intervention (after 10 sessions - approximately 5 weeks)Assessment of autism-related behavioral characteristics using the CAST questionnaire (score range depends on the Greek validated version). Higher scores indicate greater autism-related behavioral traits. Outcome analyzed as the change in CAST score from baseline to post-intervention.
Change in ADHD-Related Behavioral Indicators (ADHD Parent Questionnaire Score)Baseline and post-intervention (after 10 sessions - approximately 5 weeks)Assessment of ADHD-related behaviors using the ADHD Parent Questionnaire. Higher scores indicate more severe ADHD-related symptoms. Outcome analyzed as the change in score from baseline to post-intervention.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026