Activities and Participation of Children With Down Syndrome

Quality of Life Clinical Trial

Official title:

Investigation of Activity and Participation Levels in Children With Down Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05152251
• Other study ID #: 2021-365
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: May 2022
• Source: Hacettepe University
• Contact: Duygu Türker, PhD, PT
• Phone: 5304602723
• Email: duyguturker[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Activity
• Down Syndrome
• Participation
• Quality of Life
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Turkey	Health Sciences University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Measurement-88(GMFM-88)	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).
Primary	Participation and Environment Measure for Children and Youth(PEM-CY)	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).
Primary	Pediatric Evaluation of Disability Inventory(PEDI)	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	Pediatric Quality of Life Inventory(PedsQL)	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).
Secondary	Impact on Family Scale(IPFAM)	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).