AutismNCT06995716
Assessment Of Spinal Posture, Balance And Ankle Muscle Shortness İn 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 is to evaluate spinal posture, mobility, balance and ankle muscle shortness in children with autism. The study will feature two groups, First group will consist of children with autism Second group will consist of typically developing children Childhood autism assessment scale will be completed… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- How many people
- 36 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 25 Feb 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This study includes children with autism and typically developing children between the ages of 6-18
Who may be able to join
- Being diagnosed with autism spectrum disorder in the Special Needs Report for Children (ÇÖZGER)
- GMFCS level I or II
- Between the ages of 6-18
- IQ score of 50 or more as determined in the Special Needs Report for Children (ÇÖZGER)
- Volunteering to participate in the study
Who cannot join
- Having a rigid contracture of the columna vertebralis
- Having undergone scoliosis surgery
- 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
Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi
Düzce, Düzce, 81100
Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi
Ereğli, Zonguldak Province, 67300
About this study
The aim of this study is to evaluate spinal posture, mobility, balance and ankle muscle shortness in children with autism.
The study will feature two groups,
Read more
- First group will consist of children with autism
- Second group will consist of typically developing children
Childhood autism assessment scale will be completed with the families of the children included in the study. The tiptoe walking status of the children participating in the study will be observed and classified according to the tiptoe walking classification. Children's balance skills will be evaluated with pediatric berg balance test and timed get up and walk test, ankle muscle shortness will be evaluated with Gastro-Soleus shortness measurements, spinal posture and mobility will be evaluated with spinal mouse.
The evaluation results of both groups will be compared.
The main questions this study aims to answer are:
- Is spinal mobility decreased in children with autism compared to typically developing children?
- Is Thoracic kyphosis greater in children with autism compared to typically developing children?
- Are Balance skills poorer in children with autism compared to typically developing children?
- Does the severity of tiptoe walking increase as gastro-soleus muscle shortness increases?
- Conditions
- Autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Typically Developing Children | This group consists of typically developing children. | |
| Children With Autism | This group consists of children who have been diagnosed with autism based on "Special Needs Report for Children" (ÇÖZGER) report. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal posture and mobility
Spinal Mouse :
Spinal Mouse is a tool used for noninvasive external evaluation that measures spinal angles and shape in frontal and sagittal planes. It is used to measure spinal intersegmental angles and spinal range of motion. The device is moved over the columna vertebralis on the skin surface following the spinous processes from C7 to S3. It provides information about inclination, thorax, lumbar and sacrum/hip angles. Stores data and provides result output via computer program
Both frontal and sagittal assesment were made while standing upright
For the sagittal assesment there were 3 different evaluation positions
- Standing still
- Body flexion
- Body extension
For the frontal assesment there were 3 different evaluation positions
- Standing still
- Body left lateral flexion
- Body right lateral flexion
Measured: 6 Months
Secondary outcomes (5)
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 forms.
Measured: 6 Months
Pediatric Berg Balance Scale
It is a scale used to assess the balance of 14 functional tasks. Each item is scored between 0 and 4. A higher score represents better balance. The maximum possible score is 56.
Children were asked to complete the functional tasks and were scored accordingly to their performance.
Measured: 6 Months
Timed Up and Go Test
Children were asked to sit upright on a chair with a straight back. At the start command, the child stood up, walked 3 meters, turned around and sat back on the chair. The time taken to perform the movement was recorded in seconds and performance was interpreted accordingly
Measured: 6 Months
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: 6 Months
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: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start15 Jun 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion25 Feb 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
- 36 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
- NCT06995716
- Sponsor's protocol ID
- BAIBU-FTR-SAT-9
- Status last verified
- Sep 2025
- First submitted
- 21 May 2025
- Last updated
- 10 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Spinal Posture, Balance And Ankle Muscle Shortness İn Children With Autism
- ClinicalTrials.gov ID
- NCT06995716
- Acronym / sponsor ID
- BAIBU-FTR-SAT-9
- Conditions
- Autism
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 25 Feb 2026 (estimated)
- First posted
- 29 May 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 is to evaluate spinal posture, mobility, balance and ankle muscle shortness in children with autism.
The study will feature two groups,
- First group will consist of children with autism
- Second group will consist of typically developing children
Childhood autism assessment scale will be completed with the families of the children included in the study. The tiptoe walking status of the children participating in the study will be observed and classified according to the tiptoe walking classification. Children's balance skills will be evaluated with pediatric berg balance test and timed get up and walk test, ankle muscle shortness will be evaluated with Gastro-Soleus shortness measurements, spinal posture and mobility will be evaluated with spinal mouse.
The evaluation results of both groups will be compared.
The main questions this study aims to answer are:
- Is spinal mobility decreased in children with autism compared to typically developing children?
- Is Thoracic kyphosis greater in children with autism compared to typically developing children?
- Are Balance skills poorer in children with autism compared to typically developing children?
- Does the severity of tiptoe walking increase as gastro-soleus muscle shortness increases?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typically Developing Children | – | –This group consists of typically developing children. |
| Children With Autism | – | –This group consists of children who have been diagnosed with autism based on "Special Needs Report for Children" (ÇÖZGER) report. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study includes children with autism and typically developing children between the ages of 6-18
Key inclusion criteria (5 listed)
- Being diagnosed with autism spectrum disorder in the Special Needs Report for Children (ÇÖZGER)
- GMFCS level I or II
- Between the ages of 6-18
- IQ score of 50 or more as determined in the Special Needs Report for Children (ÇÖZGER)
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- Having a rigid contracture of the columna vertebralis
- Having undergone scoliosis surgery
- 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
Spinal posture and mobility
Time frame: 6 Months
Spinal Mouse : Spinal Mouse is a tool used for noninvasive external evaluation that measures spinal angles and shape in frontal and sagittal planes. It is used to measure spinal intersegmental angles and spinal range of motion. The device is moved over the columna vertebralis on the skin surface following the spinous processes from C7 to S3. It provides information about inclination, thorax, lumbar and sacrum/hip angles. Stores data and provides result output via computer program Both frontal and sagittal assesment were made while standing upright For the sagittal assesment there were 3 different evaluation positions * Standing still * Body flexion * Body extension For the frontal assesment there were 3 different evaluation positions * Standing still * Body left lateral flexion * Body right lateral flexion
5 secondary outcomes
Childhood Autism Rating Scale
Time frame: 6 Months
Pediatric Berg Balance Scale
Time frame: 6 Months
Timed Up and Go Test
Time frame: 6 Months
M.Gastrocnemius - M.Gastrosoleus Shortness Measurement
Time frame: 6 Months
Classification of Tiptoe Walking
Time frame: 6 Months
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 10 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 10 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?
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?
Spinal posture and mobility (time frame: 6 Months). 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 10 Sep 2025.