Clinical trial NCT06244108: Occupational Therapy Home Programs in Children With Down Syndrome
Official title: The Effect of Occupational Therapy Home Programs on Sensory Processing and Feeding Problems in Children With Down Syndrome: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Occupational Therapy
Feeding Problem
Keywords: Down Syndrome
Occupational Therapy
Home Program
Sensory Function
Randomized
Control Trial
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 38
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups. Intervention and control groups.
Primary purpose: TREATMENT

Brief summary: Children with Down Syndrome frequently encounter difficulties with sensory functions and feeding, such as oral sensory processing issues and developmental disorders. The aim of this study was to examine the effects of an Occupational Therapy Home Program on the sensory functions and feeding issues of children with Down Syndrome.

Detailed description: Although there are studies that investigate nutritional issues in children with Down syndrome, no well-structured, high-evidence, and individual-centered studies have been found. The literature assumes a relationship between the sensory functions and nutritional status of children with Down syndrome. Therefore, further studies are needed to develop intervention programs to prevent sensory processing and nutritional problems.

This study aims to evaluate the effectiveness of occupational therapy home programs in improving sensory functions and feeding problems in children with Down syndrome. The study focuses on evidence-based practices to assess the impact of these programs compared to not providing them.

The study will be conducted with children diagnosed with Down Syndrome who have applied to the Pediatrics Unit of the Department of Occupational Therapy at Hacettepe University Faculty of Health Sciences.

The study comprises pre-evaluation, final evaluation, and intervention stages. Following the initial evaluation, an occupational therapy home intervention program will be implemented for the children before and after each meal, seven days a week, for eight weeks. Evaluations will be repeated after the eight-week period.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 3-10
* Having Down Syndrome
* Families agree to participate in the study

Exclusion Criteria:

* Having previously received sensory integration and/or occupational therapy treatment
* Having a secondary diagnosis other than Down Syndrome (Mental Retardation, etc.)

Primary outcomes:
measure: Sensory Profile
timeFrame: 8 weeks
measure: Screen Tool of Feeding Problems (STEP)
timeFrame: 8 weeks
measure: Demographic Form
timeFrame: 8 weeks
measure: A meal time
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Çankaya
Study officials:
affiliation: Hacettepe University
name: Gökçen Akyürek, Assoc. Prof.
role: STUDY_DIRECTOR
References: