NCT05621135

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

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

November 4, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

November 4, 2022

Last Update Submit

February 8, 2024

Conditions

Keywords

Cerebral PalsyValidity

Outcome Measures

Primary Outcomes (5)

  • Gross Motor Function Classification System (GMFCS)

    Assessing functional level and motor functions of children with CP.

    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.

    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.

    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.

    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.

    At Baseline and 2 weeks after the baseline

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Cerebral Palsy will be participate the study between the ages of 2 and 18 years.

You may qualify if:

  • Diagnosis of Cerebral Palsy voluntary participation,
  • Age between 2-18 years

You may not qualify if:

  • Not voluntary to participate in the research,
  • Botox in the last 6 months,
  • Hip or spine surgeries in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep

Gaziantep, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Demet GÖZAÇAN KARABULUT

    Gaziantep Islam Science and Technology University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 4, 2022

First Posted

November 17, 2022

Study Start

November 15, 2022

Primary Completion

September 1, 2023

Study Completion

September 5, 2023

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations