Autism Spectrum DisorderNCT06777186
Evaluation of Motor Skills, Balance, Dual Task, and Social Adaptation in Individuals with Autism
An observational study of Autism Spectrum Disorder and Motor Disorders, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to evaluate motor skills balance, dual task and social adaptation skills in individuals with autism. Our study will be conducted in Bartın Lider Special Education and Rehabilitation Center after ethics committee approval. Read more about this study
- Who is it for?
- Ages 4 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Motor Disorders, Social Skills
- What is being tested?
- 10 meter walk test, Functional Balance and Social Adaptation Assessment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 25 Nov 2025
- 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 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: G*Power (version 3.1.9.4) package program was used for power analysis. Assuming that the effect size that could be obtained between the two groups would be large (f = 0.543 (EFFECT SIZE)), as a result of the power analysis, it was calculated that 80% power could be obtained at 90% confidence level (with a margin of error of 0.05) when at least 110 people were included in the study
Who may be able to join
- Being diagnosed with ASD by a physician
- Children are receiving education in a special education and rehabilitation center
- No vision problems
- Ability to receive and execute commands
- No cognitive problems
- No walking problems
Who cannot join
- Individuals with concomitant secondary diseases
- Individuals who have undergone surgery in the last six months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırıkkale University
Kirikkale, Kırıkkale, 71450
Alper K Gürbüz, +905364014402, alperkemal4@gmail.com
About this study
The aim of our study is to evaluate motor skills balance, dual task and social adaptation skills in individuals with autism. Our study will be conducted in Bartın Lider Special Education and Rehabilitation Center after ethics committee approval. The sample number determined by power analysis will be included in the study. Socio-demographic characteristics (age, height, body weight, body mass index, education level, exercise and smoking habits, etc.) of the individuals who voluntarily participated in the study will be obtained. The individuals participating in the study will be divided into two groups as individuals with normal motor development and individuals with autism spectrum disorder and the same assessment scales will be used. These assessment scales are TUG, 10 meter walking test, Vineland Adaptive Adaptation Scale, Bruininks-Oseretsky Motor Competence Test. According to the evaluation results, motor skills, functional balance, dual task and social adaptation skills of individuals with autism will be compared with individuals with normal motor development.
- Conditions
- Autism Spectrum Disorder, Motor Disorders, Social Skills
- Being tested
- 10 meter walk test, Functional Balance, Social Adaptation Assessment, Motor skills and proficiency
- Medical subject headings
- Autism Spectrum Disorder, Motor Disorders, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 meter walk testOther
The dual task skills of the individuals will be evaluated by adding motor and cognitive tasks to the 10-meter walk test. Tasks given to individuals
Single motor task (comfortable walking): The individual is asked to walk at normal speed, the time is recorded Motor-motor dual task: Both hands carry a half-full water bottle, time is recorded Motor-cognitive dual task (mental) : counts backwards from 10 by 1, time is recorded Motor - cognitive dual task (memory) : The individual is asked to say 3 words that were previously spoken. The time is recorded.
Functional BalanceOther
It will be assessed with the TUG test. The TUG measures the time it takes for an individual to get up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down again after a ready, go signal.
Social Adaptation AssessmentOther
Adaptive behavior will be assessed with the Vineland Adaptive Behavior Scales. It is a parent interview designed to assess functioning in daily life. [35]Specifically, adaptive behavior is assessed in four domains: Communication, Daily Living, Socialization and Motor skills. Vineland has reliability and current validity. It has been reported to be sensitive to the difficulties experienced by children with ASD
Motor skills and proficiencyOther
The Bruininks-Oseretsky Motor Proficiency Test (BOT-2) assesses fine motor, hand coordination, body coordination, strength and agility between the ages of 4-21 years.There are 53 items in the BOT-2. In BOT-2, there are four motor domains including fine motor control, hand coordination, body coordination, strength and agility and a total of eight subtests related to these domains.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Not described Receives: Other: 10 meter walk test; Other: Functional Balance; Other: Social Adaptation Assessment; Other: Motor skills and proficiency | |
| Healthy Children | Not described Receives: Other: 10 meter walk test; Other: Functional Balance; Other: Social Adaptation Assessment; Other: Motor skills and proficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meter walk test
The dual task skills of the individuals will be evaluated by adding motor and cognitive tasks to the 10-meter walk test.
Measured: At enrollment
Secondary outcomes (3)
Functional Balance
It will be assessed with the TUG test. The TUG measures the time it takes for an individual to get up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down again after a ready, go signal.
Measured: At enrollment
Social Adaptation Assessment
Adaptive behavior will be assessed with the Vineland Adaptive Behavior Scales. It is a parent interview designed to assess functioning in daily life. [35]Specifically, adaptive behavior is assessed in four domains: Communication, Daily Living, Socialization and Motor skills. Vineland has reliability and current validity. It has been reported to be sensitive to the difficulties experienced by children with ASD
Measured: At enrollment
Motor skills and proficiency
The Bruininks-Oseretsky Motor Proficiency Test (BOT-2) assesses fine motor, hand coordination, body coordination, strength and agility between the ages of 4-21 years[37] There are 53 items in the BOT-2. In BOT-2, there are four motor domains including fine motor control, hand coordination, body coordination, strength and agility and a total of eight subtests related to these domains. The highest score to be obtained from this 53-item test is 320. A short form of this test with 14 items was created, and then it was reorganized in 2010 by reducing the number of items to 12. The highest score to be obtained during the application of the test is 72.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start15 Dec 2024
- Primary completion15 May 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simay Tepik, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777186
- Sponsor's protocol ID
- Gurbuz07
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Motor Skills, Balance, Dual Task, and Social Adaptation in Individuals with Autism
- ClinicalTrials.gov ID
- NCT06777186
- Acronym / sponsor ID
- Gurbuz07
- Conditions
- Autism Spectrum Disorder, Motor Disorders, Social Skills
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 25 Nov 2025 (estimated)
- First posted
- 15 Jan 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 our study is to evaluate motor skills balance, dual task and social adaptation skills in individuals with autism. Our study will be conducted in Bartın Lider Special Education and Rehabilitation Center after ethics committee approval. The sample number determined by power analysis will be included in the study. Socio-demographic characteristics (age, height, body weight, body mass index, education level, exercise and smoking habits, etc.) of the individuals who voluntarily participated in the study will be obtained. The individuals participating in the study will be divided into two groups as individuals with normal motor development and individuals with autism spectrum disorder and the same assessment scales will be used. These assessment scales are TUG, 10 meter walking test, Vineland Adaptive Adaptation Scale, Bruininks-Oseretsky Motor Competence Test. According to the evaluation results, motor skills, functional balance, dual task and social adaptation skills of individuals with autism will be compared with individuals with normal motor development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | – | Other: 10 meter walk test, Other: Functional Balance, Other: Social Adaptation Assessment, Other: Motor skills and proficiency |
| Healthy Children | – | Other: 10 meter walk test, Other: Functional Balance, Other: Social Adaptation Assessment, Other: Motor skills and proficiency |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- G*Power (version 3.1.9.4) package program was used for power analysis. Assuming that the effect size that could be obtained between the two groups would be large (f = 0.543 (EFFECT SIZE)), as a result of the power analysis, it was calculated that 80% power could be obtained at 90% confidence level (with a margin of error of 0.05) when at least 110 people were included in the study
Key inclusion criteria (6 listed)
- Being diagnosed with ASD by a physician
- Children are receiving education in a special education and rehabilitation center
- No vision problems
- Ability to receive and execute commands
- No cognitive problems
Key exclusion criteria (2 listed)
- Individuals with concomitant secondary diseases
- Individuals who have undergone surgery in the last six months
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 |
|---|---|---|
| 10 meter walk testThe dual task skills of the individuals will be evaluated by adding motor and cognitive tasks to the 10-meter walk test. Tasks given to individuals Single motor task (comfortable walking): The individual is asked to walk at normal speed, the time is recorded Motor-motor dual task: Both hands carry a half-full water bottle, time is recorded Motor-cognitive dual task (mental) : counts backwards from 10 by 1, time is recorded Motor - cognitive dual task (memory) : The individual is asked to say 3 words that were previously spoken. The time is recorded. | Other | Autism Spectrum Disorder, Healthy Children |
| Functional BalanceIt will be assessed with the TUG test. The TUG measures the time it takes for an individual to get up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down again after a ready, go signal. | Other | Autism Spectrum Disorder, Healthy Children |
| Social Adaptation AssessmentAdaptive behavior will be assessed with the Vineland Adaptive Behavior Scales. It is a parent interview designed to assess functioning in daily life. [35]Specifically, adaptive behavior is assessed in four domains: Communication, Daily Living, Socialization and Motor skills. Vineland has reliability and current validity. It has been reported to be sensitive to the difficulties experienced by children with ASD | Other | Autism Spectrum Disorder, Healthy Children |
| Motor skills and proficiencyThe Bruininks-Oseretsky Motor Proficiency Test (BOT-2) assesses fine motor, hand coordination, body coordination, strength and agility between the ages of 4-21 years.There are 53 items in the BOT-2. In BOT-2, there are four motor domains including fine motor control, hand coordination, body coordination, strength and agility and a total of eight subtests related to these domains. | Other | Autism Spectrum Disorder, Healthy Children |
Primary outcome
10 meter walk test
Time frame: At enrollment
The dual task skills of the individuals will be evaluated by adding motor and cognitive tasks to the 10-meter walk test.
3 secondary outcomes
Functional Balance
Time frame: At enrollment
Social Adaptation Assessment
Time frame: At enrollment
Motor skills and proficiency
Time frame: At enrollment
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 15 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Motor Disorders, run by Kırıkkale University at 1 site 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 6 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: looking for participants now, as of the sponsor's last update on 15 Jan 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 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 Alper Gürbüz, Master (+905364014402, alperkemal4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meter walk test (time frame: At enrollment). 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 15 Jan 2025.