Reliability and Validity of the Turkish Version of the Object Permanence Scale

Sponsor

Tokat Gaziosmanpasa University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05749718

Collaborator

(none)

Enrollment

Location

3.9

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Developmental Delay

Study Design

Study Type:

Observational

Anticipated Enrollment :

32 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Reliability and Validity of the Turkish Version of the Object Permanence Scale

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

May 31, 2023

Outcome Measures

Primary Outcome Measures

Object Permanence Scale [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 [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.
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales [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.
Gross motor function measure sitting subscale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Months to 16 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Health Sciences, Tokat Gaziosmanpaşa University	Tokat		Turkey	60250

Sponsors and Collaborators

Tokat Gaziosmanpasa University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erkan Erol, Assistant Professor, Tokat Gaziosmanpasa University

ClinicalTrials.gov Identifier:

NCT05749718

Other Study ID Numbers:

GaziosmanpasaU_Erol_02

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 1, 2023