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NCT05152251

Activities and Participation of Children With Down Syndrome

Status unknown Last updated 26 May 2022
What this trial tests

trial testing Evaluation in Down Syndrome in 70 participants. Status unknown.

Timeline
1 February 2021
Primary endpoint
1 June 2022
1 November 2022

Quick facts

Lead sponsorHacettepe University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment70
Start date1 February 2021
Primary completion1 June 2022
Estimated completion1 November 2022
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Hacettepe University

Who can join

Adults 8 to 17, any sex, with Down Syndrome or Activity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Hacettepe University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing