Autism Spectrum Disorder (ASD)NCT07231354
Physiotherapy for Improving Mental Health in Children and Adolescents With ASD and ADHD
A study testing Structured Physiotherapy Program in people with Autism Spectrum Disorder (ASD) and Attention Deficit Hyperactivity Disorder (ADHD), run by International Hellenic University at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Neurodevelopmental Disorders
- What is being tested?
- Structured Physiotherapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteGreece
- Study dates
- 28 Jun 2022to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hippokratio General Hospital of Thessaloniki - Child Psychiatry Department
Thessaloniki, 546 42
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Neurodevelopmental Disorders
- Being tested
- Structured Physiotherapy Program
- Keywords
- Physiotherapy, Mental Health, Children, Adolescents, Exercise Therapy, Rehabilitation
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Physiotherapy ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy Intervention Group | Experimental | 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. Receives: Behavioral: Structured Physiotherapy Program |
| Comparator Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start28 Jun 2022
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel-group randomized controlled design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianna Stavropoulou, International Hellenic University
- Investigators
- Illias Kallistratos, Principal investigator, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231354
- Sponsor's protocol ID
- IHU-MST-2023-01
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant-level data will not be shared in order to protect confidentiality, as the dataset includes sensitive information from children and adolescents
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Physiotherapy in the Mental Health of Children and Adolescents With Neurodevelopmental Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07231354
- Acronym / sponsor ID
- IHU-MST-2023-01
- Conditions
- Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Neurodevelopmental Disorders
- Keywords
- Physiotherapy, Mental Health, Children, Adolescents, Exercise Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel-group randomized controlled design.
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy Intervention Group | Experimental | Behavioral: Structured Physiotherapy ProgramParticipants 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. |
| Comparator Group | No intervention | –Participants do not receive physiotherapy during the study period but continue their usual daily routines. After study completion, they are offered the physiotherapy program. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Physiotherapy ProgramA 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. | Behavioural | Physiotherapy Intervention Group |
Primary outcome
Change in Stress Levels (DASS-21 Stress Subscale)
Time frame: 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)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Change in Autism-Related Behavioral Indicators (CAST Score)
Time frame: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)
Change in ADHD-Related Behavioral Indicators (ADHD Parent Questionnaire Score)
Time frame: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No. Participant-level data will not be shared in order to protect confidentiality, as the dataset includes sensitive information from children and adolescents
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Illias Kallistratos principal investigator
International Hellenic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Physiotherapy Program in people with Autism Spectrum Disorder (ASD) and Attention Deficit Hyperactivity Disorder (ADHD), run by International Hellenic University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stress Levels (DASS-21 Stress Subscale) (time frame: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.