Down SyndromeNCT04657276
Turkish Adaptation of Segmental Assessment of Trunk Control Scale
An observational study of Down Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Down Syndrome
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Down Syndrome
Who may be able to join
- Volunteer parents who have;
- Infant with down syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Adaptation, Validity and Reliability of Segmental Assessment of Trunk Control (SATCo) Into in Infants With Down Syndrome
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.
Read the 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.
- Conditions
- Down Syndrome
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Down Syndome | Infants with Down Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 30 minutes
Secondary outcomes (2)
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
Measured: 15 minutes
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
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Jun 2021
- Primary completion15 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Kınacı Biber, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657276
- Sponsor's protocol ID
- GO 20/11
- Status last verified
- Mar 2023
- First submitted
- 1 Dec 2020
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation, Validity and Reliability of Segmental Assessment of Trunk Control (SATCo) Into in Infants With Down Syndrome
- ClinicalTrials.gov ID
- NCT04657276
- Acronym / sponsor ID
- GO 20/11
- Conditions
- Down Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Down Syndome | – | –Infants with Down Syndrome |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Down Syndrome
Key inclusion criteria (2 listed)
- Volunteer parents who have;
- Infant with down syndrome
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
2 secondary outcomes
Pediatric Quality of Life Inventory-PedsQL
Time frame: 15 minutes
Alberta Infant Motor Scale
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Segmental Assesment of Trunk Control (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.