Developmental DelayNCT05749783
Responsiveness of the Object Permanence Scale
An observational study of Developmental Delay, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is the examining responsiveness of the Object Permanence Scale. The sample of the study will be 7-16 months old babies with motor developmental delay. Inclusion criteria: 7-16 months of age, sitting for at least 3 seconds but not being able to switch independently between sitting and other… Read more about this study
- Who is it for?
- Ages 7 to 16 months
- Conditions the study is for
- Developmental Delay
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 30 Jun 2024
- Phase
- Observational
- 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 7 to 16 months
- All sexes
- Child
Study population: Infants aged 7-16 months with motor developmental delay
Who may be able to join
- 7-16 months,
- Sitting for at least 3 seconds but unable to independently switch between sitting and other positions
- To show at least one retardation in motor subscale of Bayley III.
Who cannot join
- Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Tokat Province, 60250
Erkan Erol, PhD, 05547920118, erkanerol@gmail.com
About this study
The aim of the study is the examining responsiveness of the Object Permanence Scale. The sample of the study will be 7-16 months old babies with motor developmental delay. Inclusion criteria: 7-16 months of age, sitting for at least 3 seconds but not being able to switch independently between sitting and other positions, and showing at least one developmental delay in the motor development subscale of the Bayley III Developmental Assessment. Evaluations will be done at baseline and 3 months. Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder.
- Conditions
- Developmental Delay
- Medical subject headings
- Learning Disabilities
What is being measured
The primary outcome is the main question the study is designed to answer.
Object Permanence Scale
The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.
Measured: Baseline
Object Permanence Scale
The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.
Measured: 3rd month
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales
Cognitive subscale consists of 91 items and Motor subscale consists of 138 items. Items are scored as 1 (done) and 0 (not able to). Higher scores indicate better outcome.
Measured: Baseline
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales
Cognitive subscale consists of 91 items and Motor subscale consists of 138 items. Items are scored as 1 (done) and 0 (not able to). Higher scores indicate better outcome.
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Feb 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Erol, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749783
- Sponsor's protocol ID
- GaziosmanpasaU_Erol_03
- Status last verified
- Sep 2023
- First submitted
- 19 Feb 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsiveness of the Object Permanence Scale
- ClinicalTrials.gov ID
- NCT05749783
- Acronym / sponsor ID
- GaziosmanpasaU_Erol_03
- Conditions
- Developmental Delay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 Mar 2023 (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 the study is the examining responsiveness of the Object Permanence Scale. The sample of the study will be 7-16 months old babies with motor developmental delay. Inclusion criteria: 7-16 months of age, sitting for at least 3 seconds but not being able to switch independently between sitting and other positions, and showing at least one developmental delay in the motor development subscale of the Bayley III Developmental Assessment. Evaluations will be done at baseline and 3 months. Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 16 months
- Sex
- All
- Age groups
- Child
- Study population
- Infants aged 7-16 months with motor developmental delay
Key inclusion criteria (3 listed)
- 7-16 months,
- Sitting for at least 3 seconds but unable to independently switch between sitting and other positions
- To show at least one retardation in motor subscale of Bayley III.
Key exclusion criteria (1 listed)
- Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder
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
Object Permanence Scale
Time frame: Baseline
The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.
Object Permanence Scale
Time frame: 3rd month
The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales
Time frame: Baseline
Cognitive subscale consists of 91 items and Motor subscale consists of 138 items. Items are scored as 1 (done) and 0 (not able to). Higher scores indicate better outcome.
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales
Time frame: 3rd month
Cognitive subscale consists of 91 items and Motor subscale consists of 138 items. Items are scored as 1 (done) and 0 (not able to). Higher scores indicate better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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.
Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Tokat Province, Turkey (Türkiye)
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 Developmental Delay, run by Tokat Gaziosmanpasa 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Object Permanence Scale (time frame: Baseline). The study lists 4 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 13 Sep 2023.