AutismNCT07159113
The Relationship Between Sensory Profile and Ankle Muscle Shortness in Children With Autism
An observational study of Autism, run by Abant Izzet Baysal University at 3 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the relationship between sensory profile and ankle muscle shortness in children with autism. This study will feature only one group consisting of children with autism Childhood autism assessment scale will be completed with the families of the children included in the study. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autism
- How many people
- 27 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 30 Oct 2025to 25 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: This study includes children with autism between the ages of 4-10
Who may be able to join
- Being diagnosed with autism spectrum disorder in the Special Needs Report for Children (ÇÖZGER)
- GMFCS level I,II or III
- Between the ages of 4-10
- Volunteering to participate in the study
Who cannot join
- Having a rigid contracture in passive knee extension and ankle range of motion
- History of surgery or botox affecting ankle joint range of motion in the last 6 months
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites
Bolu Abant İzzet Baysal University
Bolu, Bolu, 14030
Seda Ayaz Taş, Phd, +905495458040, seda.ayaztas@ibu.edu.tr
Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi
Düzce, Düzce, 81100
Seda Ayaz Taş, Phd, +905495458040, seda.ayaztas@ibu.edu.tr
Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi
Ereğli, Zonguldak Province, 67300
Seda Ayaz Taş, Phd, +905495458040, seda.ayaztas@ibu.edu.tr
About this study
The aim of this study was to investigate the relationship between sensory profile and ankle muscle shortness in children with autism.
This study will feature only one group consisting of children with autism
Read more
Childhood autism assessment scale will be completed with the families of the children included in the study. The tip-toe walking status of the children participating in the study will be observed and classified according to the tip-toe walking classification. The ankle muscle shortness of the children will be evaluated by Gastro-Soleus shortness measurements and sensory processing skills will be evaluated by Sensory profile.
Muscle shortness measurements and sensory profile results will be compared.
- Conditions
- Autism
- Medical subject headings
- Autistic Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Profile
This test is used to assess how children aged 3-10 years process information from their body and environment. It is a five-point Likert-type parent questionnaire and consists of 125 items. It is explained to the caregiver that he/she should check the box that best describes how often the child performs the behaviors given in the questionnaire and answer for all parameters; if he/she cannot answer because there is a behavior that he/she cannot observe at all or that he/she thinks does not fit the child, he/she should put an X on that question.
The end of each section is scored according "always" 1, "frequently" 2, "occasionally" 3, "rarely" 4, "never" 5. The scores obtained from each parameter are calculated according to the Dunn Sensory Profile Score Explanation and the child is classified according to the categories of 'definite difference', 'probable difference', 'typical performance' from each section.
Measured: One year
Secondary outcomes (3)
Childhood Autism Rating Scale
It is a scale consisting of 15 items used to assess the severity of autism, with each item scored between 1 and 4. A score of 1 represents that the child's behavior for that item is normal for his/her age, while a score of 4 represents that it is extremely abnormal. The minimum score is 15 and the maximum score is 60. The results are evaluated as "no autism" between 15-29 points, "mild-moderate autism" between 30-36 points, and extreme autism between 37-60 points. Families of the children were asked to fill out the froms.
Measured: One year
M.Gastrocnemius - M.Gastrosoleus Shortness Measurement
Passive foot dorsiflexion measurement with a manual goniometer was performed at 0 degrees knee flexion for Gastrocnemius muscle and 90 degrees knee flexion for Soleus muscle. Muscle shortness was expressed in degrees. Ankle neutral position was recorded as 0 degrees, dorsiflexion angles as positive and plantar flexion angles as negative.
Measured: One year
Classification of Tiptoe Walking
Tiptoe walking was assessed and classified by observation during 10-meter walk-run. Level 1 indicates that there is tiptoe behavior during running, walking and standing; Level 2 indicates that there is tiptoe behavior during running and walking; Level 3 indicates that there is tiptoe behavior only during running; if no tiptoe walking is observed, it was indicated as "no tiptoe walking".
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start30 Oct 2025 (estimated)
- Primary completion24 Feb 2026 (estimated)
- Study completion25 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda AYAZ TAŞ, Abant Izzet Baysal University
- Investigators
- Seda Ayaz Taş, Phd, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159113
- Sponsor's protocol ID
- BAIBU-FTR-SAT-10
- Status last verified
- Sep 2025
- First submitted
- 21 May 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sensory Profile and Ankle Muscle Shortness in Children With Autism
- ClinicalTrials.gov ID
- NCT07159113
- Acronym / sponsor ID
- BAIBU-FTR-SAT-10
- Conditions
- Autism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 24 Feb 2026 (estimated)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 8 Sep 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.
The aim of this study was to investigate the relationship between sensory profile and ankle muscle shortness in children with autism.
This study will feature only one group consisting of children with autism
Childhood autism assessment scale will be completed with the families of the children included in the study. The tip-toe walking status of the children participating in the study will be observed and classified according to the tip-toe walking classification. The ankle muscle shortness of the children will be evaluated by Gastro-Soleus shortness measurements and sensory processing skills will be evaluated by Sensory profile.
Muscle shortness measurements and sensory profile results will be compared.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study includes children with autism between the ages of 4-10
Key inclusion criteria (4 listed)
- Being diagnosed with autism spectrum disorder in the Special Needs Report for Children (ÇÖZGER)
- GMFCS level I,II or III
- Between the ages of 4-10
- Volunteering to participate in the study
Key exclusion criteria (2 listed)
- Having a rigid contracture in passive knee extension and ankle range of motion
- History of surgery or botox affecting ankle joint range of motion in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory Profile
Time frame: One year
This test is used to assess how children aged 3-10 years process information from their body and environment. It is a five-point Likert-type parent questionnaire and consists of 125 items. It is explained to the caregiver that he/she should check the box that best describes how often the child performs the behaviors given in the questionnaire and answer for all parameters; if he/she cannot answer because there is a behavior that he/she cannot observe at all or that he/she thinks does not fit the child, he/she should put an X on that question. The end of each section is scored according "always" 1, "frequently" 2, "occasionally" 3, "rarely" 4, "never" 5. The scores obtained from each parameter are calculated according to the Dunn Sensory Profile Score Explanation and the child is classified according to the categories of 'definite difference', 'probable difference', 'typical performance' from each section.
3 secondary outcomes
Childhood Autism Rating Scale
Time frame: One year
M.Gastrocnemius - M.Gastrosoleus Shortness Measurement
Time frame: One year
Classification of Tiptoe Walking
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Seda Ayaz Taş, Phd principal investigator
Abant Izzet Baysal University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by Abant Izzet Baysal University at 3 sites in Turkey (Türkiye).
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seda Ayaz Taş, Phd (+905495458040, seda.ayaztas@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Profile (time frame: One year). 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 8 Sep 2025.