Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-02 @ 6:17 AM
Study NCT ID:
NCT07023250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensorineural Hearing Loss Imprint
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'manual dexterity and coordination', 'timeFrame': 'it will be measured only one time in evaluation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sensorineural Hearing Loss']}, 'descriptionModule': {'briefSummary': 'this study will investigate the consequences of sensorineural hearing loss on manual dexterity and coordination skills in Children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Forty-five children from both genders and their ages ranged from ten to sixteen years old were recruited from Public School for the Deaf and Hard of Hearing in Banimazar district, Minia Governorate, Egypt.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders with a clinical diagnosis of severe to profound SNHL only. Their ages were between ten to sixteen years, able to understand simple instructions by sign language, able to use both upper and lower limbs, walk and practice daily living activities independently.\n\nExclusion Criteria:\n\n* Children with cochlear implantation, any cognitive, physical, visual, or neurological conditions (other than SNHI and vestibular impairment), history of previous upper, lower limbs, trunk deformity or surgery. All of these cases were confirmed by medical records and examined by a Physical therapist, Pediatrician, and Audiologist'}, 'identificationModule': {'nctId': 'NCT07023250', 'briefTitle': 'Sensorineural Hearing Loss Imprint', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Sensorineural Hearing Loss Imprint on Manual Dexterity and Coordination: Pediatric and Adolescent Innovative Study', 'orgStudyIdInfo': {'id': 'Sensorineural Hearing Loss'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sensorineural Hearing Loss Pediatric and Adolescent', 'interventionNames': ['Other: manual dexterity and coordination skills']}, {'label': 'normal group', 'interventionNames': ['Other: manual dexterity and coordination skills']}], 'interventions': [{'name': 'manual dexterity and coordination skills', 'type': 'OTHER', 'description': 'The outcomes were assessed by the use of Bruininks-Oseretsky Test scale of motor proficiency (BOT-2) subtests (3,4\\&7) for Manual Dexterity, Bilateral Coordination and Upper Limb Coordination respectively. The Bruininks-Oseretsky Examination of Motor Proficiency, Second Edition, evaluates motor performance in various areas such as Manual Dexterity, Bilateral Coordination and Upper Limb Coordination.\n\nIt utilizes subtests and complex structures to diagnose developmental and coordination issues among individuals aged four to twenty-one years old. The test is norm-referenced and purpose-oriented to assess motor abilities. The reliability and validity of the test were 0.78 and 0.84, respectively (Kosari et al., 2013; Ebrahimi et al., 2017; Yassin et al., 2020).', 'armGroupLabels': ['Sensorineural Hearing Loss Pediatric and Adolescent', 'normal group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Ahmed fekry ibrahim salman', 'investigatorAffiliation': 'Cairo University'}}}}