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Completed

NCT Number: NCT04657276

Turkish Adaptation of Segmental Assessment of Trunk Control Scale

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Esra Kınacı Biber

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Segmental Assesment of Trunk Control

    Time frame: 20 minutes

    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).

  2. Gross Motor Function Measure (GMFM-88)

    Time frame: 30 minutes

    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.

Secondary outcomes

  1. Pediatric Quality of Life Inventory-PedsQL

    Time frame: 15 minutes

    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

  2. Alberta Infant Motor Scale

    Time frame: 20 minutes

    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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 8, 2020
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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