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

NCT06864767 | Completed

• 1 other identifier: Oral Motor Functions in SMA
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Spinal Muscular Atrophy Type I

Keywords

Spinal Muscular Atrophy Type I; Oral Motor Function; Motor Function; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Neuro-sensory Motor Developmental Assessment

  The 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.

  Once, beginning of the study

• Functional Oral Intake Scale

  It 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.

  Once, beginning of the study

• Behavioral Pediatrics Feeding Assessment Scale

  The 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.

  Once, beginning of the study

Secondary Outcomes (1)

• Pediatric Quality of Life Inventory

  Once, beginning of the study

Interventions

Neuro-sensory Motor Developmental Assessment OTHER

The 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.

Functional Oral Intake Scale OTHER

It 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.

Behavioral Pediatrics Feeding Assessment Scale OTHER

The 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.

Pediatric Quality of Life Inventory OTHER

The 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.

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study was completed with 23 children between the ages of 2-4 who were followed up with the diagnosis of Spinal Muscular Atrophy (SMA) Type 1 and whose parents volunteered to participate in the study.

You may qualify if:

• Diagnosed with Spinal Muscular Atrophy Type I
• Being between the ages of 2-4
• Families volunteering to participate in the study

You may not qualify if:

• Accompanied by another chronic disease other than SMA
• The mother or father has a cognitive problem that prevents them from expressing themselves
• The mother or father is illiterate

Sponsors & Collaborators

• Zeynep HOŞBAY: lead

Study Sites (1)

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Muscular Atrophies of Childhood

Condition Hierarchy (Ancestors)

Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: May 30, 2024
• Primary Completion: June 15, 2024
• Study Completion: August 30, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)