Clinical trial NCT05152251: Activities and Participation of Children With Down Syndrome
Official title: Investigation of Activity and Participation Levels in Children With Down Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Down Syndrome
Activity
Participation
Quality of Life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gross Motor Function Measurement-88(GMFM-88)
timeFrame: 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).
measure: Participation and Environment Measure for Children and Youth(PEM-CY)
timeFrame: 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).
measure: Pediatric Evaluation of Disability Inventory(PEDI)
timeFrame: 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 outcomes:
measure: Pediatric Quality of Life Inventory(PedsQL)
timeFrame: 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).
measure: Impact on Family Scale(IPFAM)
timeFrame: 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).
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Health Sciences University
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Duygu Türker, PhD,PT
role: PRINCIPAL_INVESTIGATOR
References: