Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT06864767
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Motor and Oral Motor Function on Quality of Life in Children With SMA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014897', 'term': 'Spinal Muscular Atrophies of Childhood'}], 'ancestors': [{'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuro-sensory Motor Developmental Assessment', 'timeFrame': 'Once, beginning of the study', 'description': "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."}, {'measure': 'Functional Oral Intake Scale', 'timeFrame': 'Once, beginning of the study', 'description': '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.'}, {'measure': 'Behavioral Pediatrics Feeding Assessment Scale', 'timeFrame': 'Once, beginning of the study', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Pediatric Quality of Life Inventory', 'timeFrame': 'Once, beginning of the study', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal Muscular Atrophy Type I', 'Oral Motor Function', 'Motor Function', 'Quality of Life'], 'conditions': ['Spinal Muscular Atrophy Type I']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Spinal Muscular Atrophy Type I\n* Being between the ages of 2-4\n* Families volunteering to participate in the study\n\nExclusion Criteria:\n\n* Accompanied by another chronic disease other than SMA\n* The mother or father has a cognitive problem that prevents them from expressing themselves\n* The mother or father is illiterate'}, 'identificationModule': {'nctId': 'NCT06864767', 'briefTitle': 'Impact of Motor and Oral Motor Function on Quality of Life in Children With SMA', 'organization': {'class': 'OTHER', 'fullName': 'Biruni University'}, 'officialTitle': 'Impact of Motor and Oral Motor Function on Quality of Life in Children With Type I Spinal Muscular Atrophy', 'orgStudyIdInfo': {'id': 'Oral Motor Functions in SMA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neuro-sensory Motor Developmental Assessment', 'type': 'OTHER', 'description': "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."}, {'name': 'Functional Oral Intake Scale', 'type': 'OTHER', 'description': '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.'}, {'name': 'Behavioral Pediatrics Feeding Assessment Scale', 'type': 'OTHER', 'description': "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."}, {'name': 'Pediatric Quality of Life Inventory', 'type': 'OTHER', 'description': "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."}]}, 'contactsLocationsModule': {'locations': [{'zip': '34010', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Biruni University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeynep HOŞBAY', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Zeynep HOŞBAY', 'investigatorAffiliation': 'Biruni University'}}}}