Turkish Adaptation of Segmental Assessment of Trunk Control Scale

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04657276
Collaborator
(none)
27
1
18
1.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    27 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Turkish Adaptation, Validity and Reliability of Segmental Assessment of Trunk Control (SATCo) Into in Infants With Down Syndrome
    Actual Study Start Date :
    Jun 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Down Syndome

    Infants with Down Syndrome

    Outcome Measures

    Primary Outcome Measures

    1. Segmental Assesment of Trunk Control [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) [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 Outcome Measures

    1. Pediatric Quality of Life Inventory-PedsQL [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 24 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Esra Kınacı Ankara Turkey 06100

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Esra Kınacı, Research Assistant, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT04657276
    Other Study ID Numbers:
    • GO 20/11
    First Posted:
    Dec 8, 2020
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2022