Developmental DelayNCT07054996
Investigation of the Effects of Basic Body Awareness Training on Motor Skills İn Children at Risk of Developmental Delay
A study testing body awareness therapy and play-based exercise in people with Developmental Delay and Body Perception, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of basic body awareness training on preschool children with developmental delays. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay, Body Perception
- What is being tested?
- body awareness therapy and play-based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2025to Dec 2025
- Phase
- Interventional
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4 to 6 years attending preschool
- Those who voluntarily agreed to participate in the study
Who cannot join
- Children with neurological problems
- Children who are uncooperative
- Children receiving speech and language therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ŞEYMA ASLAN contact
Turkey (Türkiye)1 site
Milli Eğitim
Sanliurfa
harran lecturer, 05387466854, hilalaslan@harran.edu.tr
About this study
Official title: Investigation of the Effects of Basic Body Awareness Training on Motor Skills, Play Skills, and Social Participation in Children at Risk of Developmental Delay
The aim of this study is to investigate the effects of basic body awareness training on preschool children with developmental delays.
Read the detailed description
In this study, the effects of basic body awareness training and play-based exercise will be investigated in children with developmental delays. These effects will be evaluated in terms of motor skills, play skills, and social participation
- Conditions
- Developmental Delay, Body Perception
- Being tested
- body awareness therapy, play-based exercise
- Keywords
- basic body awareness therapy, Motor development, Body perception, Mental rotation, developmental delay
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body awareness therapyOther
Basic body awareness training will be applied to preschool children in terms of motor development and body perception
play-based exerciseOther
Play-based exercise training will be implemented for preschool children by designing games that they enjoy playing, in order to support motor development and body perception.
| Study group | Role | What they receive |
|---|---|---|
| Basic Body Awareness Group | Experimental | This group will receive basic body awareness training Receives: Other: body awareness therapy |
| Play-based Exercise Group | Experimental | An obstacle course will be set up for this group and play-based exercise methods will be implemented. Receives: Other: play-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
motor development
Bruininks-Oseretsky Test of Motor Proficiency. A person can receive a maximum raw score of 72 on the test. A higher score indicates better motor proficiency.
Measured: 1. week- 12. week
body perception
A web-based application will be designed for body perception to help children recognize the parts of their own body using body part images, distinguish between right and left, and measure their reaction speed based on their correct responses to these images
Measured: 1. week- 12. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DelayStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HİLAL DOĞAN, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054996
- Sponsor's protocol ID
- 2025/083
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD used only for the publication of the results
Publications
Jones RA, Riethmuller A, Hesketh K, Trezise J, Batterham M, Okely AD. Promoting fundamental movement skill development and physical activity in early childhood settings: a cluster randomized controlled trial. Pediatr Exerc Sci. 2011 Nov;23(4):600-15. doi: 10.1123/pes.23.4.600.
PubMed 22109783
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Basic Body Awareness Training on Motor Skills, Play Skills, and Social Participation in Children at Risk of Developmental Delay
- ClinicalTrials.gov ID
- NCT07054996
- Acronym / sponsor ID
- 2025/083
- Conditions
- Developmental Delay, Body Perception
- Keywords
- basic body awareness therapy, Motor development, Body perception, Mental rotation, developmental delay
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Jul 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 investigate the effects of basic body awareness training on preschool children with developmental delays.
Detailed description
In this study, the effects of basic body awareness training and play-based exercise will be investigated in children with developmental delays. These effects will be evaluated in terms of motor skills, play skills, and social participation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic Body Awareness Group | Experimental | Other: body awareness therapyThis group will receive basic body awareness training |
| Play-based Exercise Group | Experimental | Other: play-based exerciseAn obstacle course will be set up for this group and play-based exercise methods will be implemented. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 4 to 6 years attending preschool
- Those who voluntarily agreed to participate in the study
Key exclusion criteria (3 listed)
- Children with neurological problems
- Children who are uncooperative
- Children receiving speech and language therapy
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 |
|---|---|---|
| body awareness therapyBasic body awareness training will be applied to preschool children in terms of motor development and body perception | Other | Basic Body Awareness Group |
| play-based exercisePlay-based exercise training will be implemented for preschool children by designing games that they enjoy playing, in order to support motor development and body perception. | Other | Play-based Exercise Group |
Primary outcome
motor development
Time frame: 1. week- 12. week
Bruininks-Oseretsky Test of Motor Proficiency. A person can receive a maximum raw score of 72 on the test. A higher score indicates better motor proficiency.
body perception
Time frame: 1. week- 12. week
A web-based application will be designed for body perception to help children recognize the parts of their own body using body part images, distinguish between right and left, and measure their reaction speed based on their correct responses to these images
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 Jul 2025.
- Background: PubMed 22109783Jones RA, Riethmuller A, Hesketh K, Trezise J, Batterham M, Okely AD. Promoting fundamental movement skill development and physical activity in early childhood settings: a cluster randomized controlled trial. Pediatr Exerc Sci. 2011 Nov;23(4):600-15. doi: 10.1123/pes.23.4.600.
- Individual participant dataSharing planned: No. IPD used only for the publication of the results
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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.
ŞEYMA ASLAN contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing body awareness therapy and play-based exercise in people with Developmental Delay and Body Perception, run by Harran 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 2 inclusion and 3 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 Jul 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 hilal doğan (05387466854, hilalaslan@harran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor development (time frame: 1. week- 12. week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07054996, which also lists 1 linked publication.
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 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.