Cerebral PalsyNCT05621135
Validity and Reliability of the Sitting Assessment Scale in Cerebral Palsy
An observational study of Cerebral Palsy, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial summary
The Sitting Assessment Scale is a valid and reliable scale that evaluates sitting balance in Cerebral Palsy (CP). The validity and reliability study of the scale has been done, but it has not been adapted to Turkish language. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 5 Sep 2023
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cerebral Palsy will be participate the study between the ages of 2 and 18 years.
Who may be able to join
- Diagnosis of Cerebral Palsy voluntary participation,
- Age between 2-18 years
Who cannot join
- Not voluntary to participate in the research,
- Botox in the last 6 months,
- Hip or spine surgeries in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The Sitting Assessment Scale is a valid and reliable scale that evaluates sitting balance in Cerebral Palsy (CP). The validity and reliability study of the scale has been done, but it has not been adapted to Turkish language. The aim of this study is to adapt the Sitting Evaluation Scale, which evaluates sitting balance in Cerebral Palsy, into Turkish and to examine the validity and reliability of the Turkish version of the scale.
Read the detailed description
Cerebral Palsy will be participate the study between the ages of 2 and 18 years. Children's classified with GMFCS and MACS.
Evaluation will be applied to the volunteer participants after the translation steps of the Sitting Evaluation Assessment are completed. The validity of the scale will be examined in terms of construct validity and content validity. All evaluations will be performed in the clinic with the specialist physiotherapist.
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Validity
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Classification System (GMFCS)
Assessing functional level and motor functions of children with CP.
Measured: At Baseline
Manuel ability classification system (MACS)
This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function.
Measured: At Baseline
Gross Motor Function Measure-88
It is used to show gross motor functions and changes in these functions. It consists of five main sections. Each section can be used by calculating separately within itself. The total score ranges from 0 to 100, with a high score indicating better function.
Measured: At Baseline
Trunk Control Measurement Scale
This scale consists of two main parts as dynamic and static sitting balance. The scale consists of 15 questions. The scoring of the items is 0, 1, 2 or 3. The total score ranges from 0 to 58, with a high score indicating better trunk control.
Measured: At Baseline
Sitting Assessment Scale
The Sitting Assessment Scale is a standard observation tool designed for the assessment of sitting in children with CP. The scale consists of five items evaluating head, trunk and foot control and arm and hand functions.The lowest score that can be obtained from the scale is 5 and the highest score is 20. It can be stated that higher scores better functions.
Measured: At Baseline and 2 weeks after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start15 Nov 2022
- Primary completion1 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet GÖZAÇAN KARABULUT, Gaziantep Islam Science and Technology University
- Investigators
- Demet GÖZAÇAN KARABULUT, Study director, Gaziantep Islam Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621135
- Sponsor's protocol ID
- GIBTU-FTR-DGK-2
- Status last verified
- Feb 2024
- First submitted
- 4 Nov 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Sitting Assessment Scale in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05621135
- Acronym / sponsor ID
- GIBTU-FTR-DGK-2
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 17 Nov 2022 (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.
The Sitting Assessment Scale is a valid and reliable scale that evaluates sitting balance in Cerebral Palsy (CP). The validity and reliability study of the scale has been done, but it has not been adapted to Turkish language. The aim of this study is to adapt the Sitting Evaluation Scale, which evaluates sitting balance in Cerebral Palsy, into Turkish and to examine the validity and reliability of the Turkish version of the scale.
Detailed description
Cerebral Palsy will be participate the study between the ages of 2 and 18 years. Children's classified with GMFCS and MACS.
Evaluation will be applied to the volunteer participants after the translation steps of the Sitting Evaluation Assessment are completed. The validity of the scale will be examined in terms of construct validity and content validity. All evaluations will be performed in the clinic with the specialist physiotherapist.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cerebral Palsy will be participate the study between the ages of 2 and 18 years.
Key inclusion criteria (2 listed)
- Diagnosis of Cerebral Palsy voluntary participation,
- Age between 2-18 years
Key exclusion criteria (3 listed)
- Not voluntary to participate in the research,
- Botox in the last 6 months,
- Hip or spine surgeries in the last 6 months
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
Gross Motor Function Classification System (GMFCS)
Time frame: At Baseline
Assessing functional level and motor functions of children with CP.
Manuel ability classification system (MACS)
Time frame: At Baseline
This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function.
Gross Motor Function Measure-88
Time frame: At Baseline
It is used to show gross motor functions and changes in these functions. It consists of five main sections. Each section can be used by calculating separately within itself. The total score ranges from 0 to 100, with a high score indicating better function.
Trunk Control Measurement Scale
Time frame: At Baseline
This scale consists of two main parts as dynamic and static sitting balance. The scale consists of 15 questions. The scoring of the items is 0, 1, 2 or 3. The total score ranges from 0 to 58, with a high score indicating better trunk control.
Sitting Assessment Scale
Time frame: At Baseline and 2 weeks after the baseline
The Sitting Assessment Scale is a standard observation tool designed for the assessment of sitting in children with CP. The scale consists of five items evaluating head, trunk and foot control and arm and hand functions.The lowest score that can be obtained from the scale is 5 and the highest score is 20. It can be stated that higher scores better functions.
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 9 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Demet GÖZAÇAN KARABULUT study director
Gaziantep Islam Science and Technology University
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 Cerebral Palsy, run by Gaziantep Islam Science and Technology 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 3 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 9 Feb 2024. 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?
Gross Motor Function Classification System (GMFCS) (time frame: At Baseline). The study lists 5 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 9 Feb 2024.