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

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.

Study Overview

• Status: Completed
• Conditions: Neurodevelopmental Disorders; Attention Deficit Hyperactivity Disorder (ADHD); Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Behavioral: Structured Physiotherapy Program

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 546 42
    • Hippokratio General Hospital of Thessaloniki - Child Psychiatry Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Structured Physiotherapy Program; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress Levels (DASS-21 Stress Subscale)	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.	Baseline and post-intervention (after 10 sessions - approximately 5 weeks)
Change in Anxiety Levels (DASS-21 Anxiety Subscale)	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.	Baseline and post-intervention (after 10 sessions - approximately 5 weeks)
Change in Depression Levels (DASS-21 Depression Subscale)	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.	Baseline and post-intervention (after 10 sessions - approximately 5 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Autism-Related Behavioral Indicators (CAST Score)	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.	Baseline and post-intervention (after 10 sessions - approximately 5 weeks)
Change in ADHD-Related Behavioral Indicators (ADHD Parent Questionnaire Score)	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.	Baseline and post-intervention (after 10 sessions - approximately 5 weeks)

Collaborators and Investigators

• Sponsor: International Hellenic University
• Investigators: Principal Investigator: Illias Kallistratos, International Hellenic University

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Rehabilitation; Mental Health; Children; Physiotherapy; Exercise Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Child Development Disorders, Pervasive; Attention Deficit and Disruptive Behavior Disorders; Behavior; Personal Satisfaction; Autism Spectrum Disorder; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Psychological Well-Being
• Other Study ID Numbers: IHU-MST-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant-level data will not be shared in order to protect confidentiality, as the dataset includes sensitive information from children and adolescents

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No