Clinical Trials Directory

Trials / Completed

CompletedNCT06864767

Impact of Motor and Oral Motor Function on Quality of Life in Children With SMA

Impact of Motor and Oral Motor Function on Quality of Life in Children With Type I Spinal Muscular Atrophy

Status
Completed
Phase
Study type
Observational
Enrollment
23 (actual)
Sponsor
Zeynep HOŞBAY · Academic / Other
Sex
All
Age
2 Years – 4 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to investigate the impact of motor and oral motor functions on the quality of life in children aged 2-4 years diagnosed with Spinal Muscular Atrophy (SMA) Type I. In the study, the Neuro-Sensory-Motor Developmental Assessment (NSMDA) was used to evaluate motor functions, the Functional Oral Intake Scale (FOIS) to assess oral motor function, the Behavioral Pediatric Feeding Assessment Scale (BPFAS) to evaluate children's attitudes towards feeding, and the Pediatric Quality of Life Inventory (PedsQL) Neuromuscular Module to assess quality of life.

Conditions

Interventions

TypeNameDescription
OTHERNeuro-sensory Motor Developmental AssessmentThe test used to assess children's development levels evaluates the child's development in six parameters: gross motor function, fine motor function, neurological status, infant movement patterns, postural development and sensory-motor function (tactile, proprioceptive, ocular and vestibular systems) on a scale of 1 to 5. High scores are interpreted as motor dysfunction.
OTHERFunctional Oral Intake ScaleIt is a scale consisting of a total of 7 levels and two sections, developed by Crary et al. to indicate the functional oral intake of patients with dysphagia. A higher score indicates a better nutritional level.
OTHERBehavioral Pediatrics Feeding Assessment ScaleThe scale used to determine eating problems in children evaluates both the child's nutritional status and the parents' feelings about the child's nutritional status. It consists of 35 items in total and is scored from 1 to 5. High scores indicate problematic eating behaviors and habits.
OTHERPediatric Quality of Life InventoryThe PedsQL assesses health-related quality of life in children ages 2 to 18 years with chronic illnesses from both the child's and parents' perspectives. It consists of 25 items and 3 categories (About My Child's Neuromuscular Disease, Communication, About Our Family Resources). The Neuromuscular Module was used to assess the quality of life of the children in our study and was answered by the parents only. The scale is scored from 0 to 4, with higher scores indicating better quality of life.

Timeline

Start date
2024-05-30
Primary completion
2024-06-15
Completion
2024-08-30
First posted
2025-03-07
Last updated
2025-03-07

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06864767. Inclusion in this directory is not an endorsement.