Activities and Participation of Children With Down Syndrome

May 24, 2022 updated by: Duygu Turker, Hacettepe University

Investigation of Activity and Participation Levels in Children With Down Syndrome

The aim of this study is to examine the activity participation levels of Down syndrome(DS) children and the restrictive or supportive factors affecting their participation levels and to investigate their effects on quality of life. 35 children diagnosed with DS by a pediatric neurologist and 35 typically developing children are planned to be included in this study. Sociodemographic data of typically developing and DS children who agreed to participate in the study and their families will be questioned. Activity (Gross Motor Function Measurement-GMFM-88) , participation and the effect of the environment on participation (Participation and Environment Measure for Children and Youth-PEM-CY ), reflection of motor development levels to functions in daily living activities (Pediatric Evaluation of Disability Inventory- PEDI) , quality of life(Pediatric Quality of Life Inventory- PedsQL) and familial impact (Impact on Family Scale-IPFAM) will be evaluated. Evaluation methods to be used in our study will be applied one-on-one with children and face-to-face interviews with their parents. Our study is important in that there is little evidence on participation studies in children and that changing medical paradigms emphasize the quality of life of children. In addition, the PEM-CY the investigators will use in the study will make the study more valuable as it examines the effect of the environment on participation and evaluates participation in different environments.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to examine the activity participation levels of DS children and the restrictive or supportive factors affecting their participation levels and to investigate their effects on quality of life. 35 children diagnosed with DS by a pediatric neurologist and 35 typically developing children are planned to be included in this study. In line with the power analysis, a study should be conducted with a total of 52 individuals, 26 individuals in each group, with 95% confidence (1-α), 95.0% test power (1-β) and d=1.50 (large) effect size . Considering the 25% loss of individuals in the groups during the evaluation period, it was decided that forming each group with at least 35 children would increase the power of the study, and the study will be concluded with at least 70 individuals.Sociodemographic data of typically developing and DS children who agreed to participate in the study and their families will be questioned. Sociodemographic data will include information about age, height, weight, gender, body mass index, education level of the child, place of residence, physical therapy and special education session received by the child, assistive devices used, comorbidities of the child (cardiovascular anomalies, pulmonary problems, oral disorders, gastrointestinal disorders, overweight and obesity, musculoskeletal disorders, epilepsy), age of parents, education level, occupation, marital status, average income . Activity (Gross Motor Function Measurement-GMFM-88) , participation and the effect of the environment on participation (Participation and Environment Measure for Children and Youth -PEM-CY), reflection of motor development levels to functions in daily living activities (Pediatric Evaluation of Disability Inventory- PEDI) , quality of life(Pediatric Quality of Life Inventory- PedsQL) and familial impact (Impact on Family Scale-IPFAM) will be evaluated. Evaluation methods to be used in our study will be applied one-on-one with children and face-to-face interviews with their parents. The data to be obtained from the study will be analyzed using appropriate statistical methods. Statistical analyzes will be made using the Windows compatible Statistical Package for Social Science(SPSS) 20.0 package program. Data indicated by measurement will be expressed as arithmetic mean and standard deviation, data indicated by counting will be expressed as n and percentage (n,%). In the comparison of the groups, the t test will be used when parametric conditions are met, and the Mann Whitney U test will be used in cases where they are not met. The P value will be taken as 0.05. The investigators think that the results of the study can provide a new perspective to clinicians and researchers working in the field of rehabilitation in order to support the participation of DS children and young people in social life and can support social support projects and policies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Health Sciences University
        • Contact:
        • Principal Investigator:
          • Duygu TÜRKER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will include children with DS between the ages of 8-17, who can cooperate, who are not visually and/or hearing impaired, and typically developing children between the ages of 8-17 who are not diagnosed with any disease, and their literate parents.

Description

Inclusion Criteria:

  • Children with DS aged 8-17 years, who can cooperate, who have no visual and/or hearing impairment
  • Typical developing children aged 8-17 years who are not diagnosed with any disease
  • Parents who can read and write

Exclusion Criteria:

  • Children and their families who did not want to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study Group
Down Syndrome
Other: Evaluation
Individuals' activity participation levels and the restrictive or supportive factors affecting their participation levels and their effects on quality of life will be evaluated.
Control Group
Typically Developing Children
Other: Evaluation
Individuals' activity participation levels and the restrictive or supportive factors affecting their participation levels and their effects on quality of life will be evaluated.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measurement-88(GMFM-88)
Time Frame: The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).
The measurement assesses gross motor functions in children aged 5 months to 16 years.Although GMFM-88 was developed for children with Cerebral palsy (CP), it has also been validated for other populations such as children with DS and acquired brain injury.GMFM-88 consists of 88 items in total, including supine-prone position and rolling (A=17), sitting (B=20), crawling-kneeling (C=14), standing (D=13), walking-running-jumping (E=24) subsections. Gross motor functions in these items are evaluated according to the degree of achievement. Scoring is done according to the Likert scale: 0 means that the activity has never been started, and 3 means that 90% - 100% of the activity can be done.
The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).
Participation and Environment Measure for Children and Youth(PEM-CY)
Time Frame: The measurements will start with the first child (estimated in November 2021) and will end with the evaluation of the 70th child(estimated in May 2022).
The PEM-CY is a parent report questionnaire used to assess participation and environmental factors in children and adolescents aged 5-17 years at home, at school, and in community settings. Items for each environment generally represent the types of activities performed in that setting; The engagement sections include 10 activities in the home environment, 5 activities in the school environment, and 10 activities in the community setting.For each type of activity, the parent is asked to rate how often (for the last 4 months) the child participates (eight options: daily to never), how much the child is typically involved during participation on a 5-point Likert scale, and whether the parent would like to see the child participate in this type of activity change.After answering the participation section, parents are asked to rate environmental features to identify supports and barriers.
The measurements will start with the first child (estimated in November 2021) and will end with the evaluation of the 70th child(estimated in May 2022).
Pediatric Evaluation of Disability Inventory(PEDI)
Time Frame: The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).
PEDI comprehensively assesses functional ability and performance in children with disabilities. The functional skills section, which measures the functional abilities of the child, consists of a total of 197 items including the Self-Care (73), Mobility (59) and Social Function (65) subscales. Rating 0; cannot and 1; is done as can be done. At the end of each sub-scale, the scores of that scale are summed up and the Functional Skills Total Score is obtained by adding the scores of the sub-scales.
The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pediatric Quality of Life Inventory(PedsQL)
Time Frame: The measurements will start with the first child (estimated in November 2021) and will end with the evaluation of the 70th child(estimated in May 2022).
It is a general quality of life scale that evaluates the physical and psychosocial lives of children between the ages of 2-18 independently of the disease. The scale, prepared for the 8-12 and 13-18 age groups, has a parent and child form. Scoring of the 23-item scale, which is suitable for use in both healthy and diseased children and adolescents, is done in 3 areas (total score, physical health, emotional social school functionality). The higher the total score, the better the health-related quality of life is perceived.
The measurements will start with the first child (estimated in November 2021) and will end with the evaluation of the 70th child(estimated in May 2022).
Impact on Family Scale(IPFAM)
Time Frame: The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).
It was developed to easily measure the impact on the families of children with chronic disabilities. It evaluates the level of influence of the family under 4 main headings: financial burden, familial and social impact, personal difficulty, coping, and the total impact score can be calculated by the sum of these parameters. The scale has a 4-point Likert type evaluation. A minimum of 24 and a maximum of 96 points can be obtained from the scale.
The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Duygu Türker, PhD,PT, Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-365

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings