Activities and Participation of Children With Down Syndrome

NCT05152251 | Unknown

• 1 other identifier: 2021-365
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Activity; Participation; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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).

• 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).

• 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 Outcomes (2)

• Pediatric Quality of Life Inventory(PedsQL)

  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)

  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).

Study Arms (2)

Study Group

Down Syndrome

Other: Evaluation

Control Group

Typically Developing Children

Other: Evaluation

Interventions

Evaluation OTHER

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; Study Group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Health Sciences University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Down Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Behavior

Study Officials

• Duygu Türker, PhD,PT

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duygu Türker, PhD, PT

CONTACT

5304602723; duyguturker@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 9, 2021
• Study Start: February 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

TU (1)