A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities

Study Overview
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Brief Summary
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A Longitudinal Study of Function and Participation in Life Activities of Patients with Developmental Disabilities

Detailed Description
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Developmental Disabilities (DD) is defined as a group of neurodevelopmental issues, leading to significant lag in one or more areas (e.g. cognition, speech, motor, self-care and psychosocial function) for various reasons. On the basis of International Classification of Functioning, Disability and Health -Children and Youth Version (ICF-CY) framework, problems related to Developmental Disabilities further limit activities of daily living (ADL) and participation of patients.

Official Title
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A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities

Conditions
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Child Development Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Developmental Disabilities Age 0-25 y/o Agree to sign informed consent Exclusion Criteria: Active medical condition (e.g. infection) Concurrent progressive or degenerative disease (e.g. neurogenerative disease) Concurrent illness or disease not typically associated with DD (e.g. pneumonia)

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Control: Healthy child | |
| Experimental<br>Patients with Developmental Disabilities | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of general developmental for Healthy child and patients with Developmental Disabilities in 6 months and 12 months | Comprehensive Developmental Inventory for Infants and Toddlers | baseline, 6 months, 12 months | 
| Change from baseline of body function & structures in 6 months and 12 months | Bruininks- Oseretsky Test of Motor Proficiency II | baseline, 6 months, 12 months | 
| Change from baseline of upper extremity function & structures in 6 months and 12 months | Quality of upper extremity skills test | baseline, 6 months, 12 months | 
| Change from baseline of lower extremity function & structures in 6 months and 12 months | Pediatric Balance Scale | baseline, 6 months, 12 months | 
| Change from baseline of Sensory and Perceptual function in 6 months and 12 months | Sensory Profile | baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of activities in 6 months and 12 months | Functional Independence Measure for Children | baseline, 6 months, 12 months | 
| Change from baseline of Participation in 6 months and 12 months | Children Assessment of Participation and Enjoyment, Preferences for Activity of Children | baseline, 6 months, 12 months | 
| Change from baseline of Quality of Life in 6 months and 12 months | TNO-AZL Child Quality of Life Questionnaire | baseline, 6 months, 12 months | 
| Change from baseline of Personal & Environment factor in 6 months and 12 months | Parenting Stress Index, | baseline, 6 months, 12 months | 
| Change from baseline of Rehabilitation & community service factor in 6 months and 12 months | Measure of Processes of Care | baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Developmental Disabilities, Body function and body structure, Participation, Life activities, Quality of Life