Turkish Adaptation of Segmental Assessment of Trunk Control Scale

Down Syndrome Clinical Trial

Official title:

Turkish Adaptation, Validity and Reliability of Segmental Assessment of Trunk Control (SATCo) Into in Infants With Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657276
• Other study ID #: GO 20/11
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In infants with Down syndrome at risk in terms of neurosensory motor development retardation, the level of trunk control can determine the level of trunk control towards motor development in infants with down syndrome.

For this reason, the purpose of this study is to adapt the segmental assessment of trunk control scale to Turkish by evaluating the motor development in children with Down syndrome. It is the investigation of validity and reliability.

Description:

Independent sitting of babies with Down syndrome is very important because sitting is the primary position on improving play activities. It is a known fact that late acquisition of sitting posture has negative effects on gross motor skills such as crawling and walking as well as fine motor skills. The extent to which trunk development affects the developmental stages of the child and his performance in motor behaviors and skills should be evaluated. At the same time, trunk control should be evaluated at various periods in order to determine early intervention and treatment strategies in babies with Down syndrome who are at risk for motor development.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 30, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

• Volunteer parents who have;

• Infant with down syndrome

Exclusion Criteria:

• Have a serious medical history (serious cardiac problems, infantile spasm, leukemia)

• Presence of MSS and PSS-related problems

• Those with visual and auditory problems

• Having epileptic seizures

• Presence of musculoskeletal problems

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Locations

Country	Name	City	State
Turkey	Esra Kinaci Biber	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Segmental Assesment of Trunk Control	It is an evaluation method that allows to evaluate the body control as static, active and reactive control, according to the body control levels. Examines the development of trunk control from level 1 (head control) and level 7 (full trunk control).	20 minutes
Primary	Gross Motor Function Measure (GMFM-88)	The Gross Motor Function Measure (GMFM) is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy. tem scoring is the same for the GMFM-88. There is a scoring system with each item scored as 0, 1, 2, 3, or "not tested". A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. High total score represents good development.	30 minutes
Secondary	Pediatric Quality of Life Inventory-PedsQL	PedsQL ™ Infant Scale; On the PedsQL Generic Core Scales, for ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL	15 minutes
Secondary	Alberta Infant Motor Scale	Alberta Infant Motor Scale The total raw score is the sum of the scores for the four positions, which can range between 0 to 58; higher scores indicate better motor development. The total raw score is converted to an age-based percentile rank, varying from 5 to 90% for comparison norms	20 minutes