Responsiveness of the Object Permanence Scale

Developmental Delay Clinical Trial

Official title:

Responsiveness of the Object Permanence Scale

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749783
• Other study ID #: GaziosmanpasaU_Erol_03
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 7 Months to 16 Months

Eligibility

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

Related Conditions & MeSH terms

• Developmental Delay

Locations

Country	Name	City	State
Turkey	Faculty of Health Sciences, Tokat Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Object Permanence Scale	The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.	Baseline
Primary	Object Permanence Scale	The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.	3rd month
Primary	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.	Baseline
Primary	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.	3rd month