NCT04657276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 30, 2026

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

December 1, 2020

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Pediatric Quality of Life Inventory-PedsQL

    15 minutes

  • Alberta Infant Motor Scale

    20 minutes

Study Arms (1)

Down Syndome

Infants with Down Syndrome

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Down Syndrome

You may qualify if:

  • Volunteer parents who have;
  • Infant with down syndrome

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Kınacı Biber

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 8, 2020

Study Start

June 1, 2021

Primary Completion

October 15, 2022

Study Completion

December 30, 2022

Last Updated

January 30, 2026

Record last verified: 2023-03

Locations