- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05749718
Reliability and Validity of the Turkish Version of the Object Permanence Scale
September 11, 2023 updated by: Erkan Erol, Tokat Gaziosmanpasa University
The aim of the study is the cultural adaptation of the Object Permanence Scale to Turkish and to examine its validity and reliability.
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 after 1 week (retest).
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 Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tokat, Turkey, 60250
- Recruiting
- Faculty of Health Sciences, Tokat Gaziosmanpaşa University
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Contact:
- Erkan Erol, PhD
- Phone Number: 05547920118
- Email: erkanerol@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 1 year (Child)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Infants aged 7-16 months with motor developmental delay
Description
Inclusion Criteria:
- 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.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Baseline
|
Object Permanence Scale
Time Frame: After 1 week (retest)
|
The minimum score of the Object Permanence Scale is 0, and the maximum score is 10.
Higher scores indicate better outcome.
|
After 1 week (retest)
|
Gross motor function measure sitting subscale
Time Frame: Baseline
|
The sitting subscale consists of 20 items.
Each item is scored on a 4-point ordinal scale (0-3).
Higher scores indicate better outcome.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
February 19, 2023
First Submitted That Met QC Criteria
February 19, 2023
First Posted (Actual)
March 1, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- GaziosmanpasaU_Erol_02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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