Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
Study NCT ID:
NCT04788134
Status:
UNKNOWN
Last Update Posted:
2021-03-09
First Post:
2021-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post- Rotatory Nystagmus Test: Normative Data for Spanish Adolescents and Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009759', 'term': 'Nystagmus, Pathologic'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 163}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2021-03-04', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of vestibular-ocular reflex after the administration of nystagmus post-rotatory test in adolescent and adult population', 'timeFrame': 'End of the nystagmus post rotatory test and end of the vestibular-ocular reflex', 'description': 'The post rotatory nystagmus test evaluates the duration of the vestibular-ocular reflex: how long its lats gives information about the perception of vestibular system. This reflex reflects the role of the vestibular system in ocular mechanisms (Mailloux et al., 2014). It is administered twice: clockwise and counterclockwise.After the administration the physiologic nystagmus appears, it is our vestibular-ocular reflex, and the examiner has to register the duration of it.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vestibular function tests', 'nystagmus, physiologic', 'adult', 'adolescent'], 'conditions': ['Vestibular Function Tests', 'Nystagmus Vestibular']}, 'referencesModule': {'references': [{'pmid': '25184463', 'type': 'RESULT', 'citation': 'Mailloux Z, Leao M, Becerra TA, Mori AB, Soechting E, Roley SS, Buss N, Cermak SA. Modification of the postrotary nystagmus test for evaluating young children. Am J Occup Ther. 2014 Sep-Oct;68(5):514-21. doi: 10.5014/ajot.2014.011031.'}]}, 'descriptionModule': {'briefSummary': 'The vestibulo-ocular reflex is the motor response of our eyes in the opposite direction to a translational or rotational movement of our head. The post-rotational nystagmus test (PRN) assesses the integrity of this reflex, thus assessing the perception of the vestibular system. The duration of this reflex after administering this test has been widely studied in children from 2 months to 12 years and 11 months of age. However, there is a knowledge gap from that age that the present study seeks to address.', 'detailedDescription': 'The vestibulo-ocular reflex (VOR) is the motor response of our eyes in the opposite direction to a translational or rotational movement of our head. The post-rotational nystagmus test (PRN) assesses the integrity of this reflex, thus assessing the perception of the vestibular system. This system has an important role in our balance, stabilization of the visual field when our head moves, awareness of the position of our head in space, postural control and functions of the Autonomous Nervous System.\n\nThe duration of this reflex after administering this test has been widely studied in children from 2 months to 12 years and 11 months of age. However, there is a knowledge gap from that age that the present study seeks to address. This article aims to explore the use of the PRN test for adolescent and adults, to prove if the duration of the VOR is longer in these population than in children. It will be also recollected personal data to study whether exposure to vestibular input influences its reactivity and perception.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People over 13 years, that lives in the north, middle and south of Spain, and meet the selection criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People over 13 years of age.\n* Spanish-speaking population.\n* Signature of the informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of a neurodevelopmental or neurological disorder.\n* Being in occupational therapeutic treatment for balance or vestibular problems.\n* Practice of sports in one previous hour.\n* Adverse reaction to vestibular input such as vomiting, discoloration, feeling of unpleasantness or any other type of negative reaction before / during / after the administration of the NPR.'}, 'identificationModule': {'nctId': 'NCT04788134', 'briefTitle': 'Post- Rotatory Nystagmus Test: Normative Data for Spanish Adolescents and Adults', 'organization': {'class': 'INDIV', 'fullName': 'Quesada, Rocío Vico'}, 'officialTitle': 'Normative Data for Post-rotatory Nystagmus Test at Spanish Adolescent and Adult Population: a Transversal Study', 'orgStudyIdInfo': {'id': '010395'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Post-rotatory nystagmus test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The test is administrated with the person sit down with cross legs at a rotatory board, with the head positioned by the examiner in 30° of forward flexion. The position was maintained by the administration of the test. The administration consist in two administrations separate by one minute. Each administration consist in rotate the person 10 times in 20 seconds (the first 10 rotations in a counterclockwise direction in 20 s and the second 10 rotations in a clockwise direction in 20 s). After each administration the examiner counts the duration of the reflex in seconds.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vico Rocío', 'role': 'CONTACT', 'email': 'rociovicoquesada@gmail.com', 'phone': '+34 658144741'}, {'name': 'Pedrero Yolanda', 'role': 'CONTACT', 'email': 'yolandapedmar@hotmail.com', 'phone': '+ 34 697355054'}], 'overallOfficials': [{'name': 'Vico Rocío', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quesada, Rocío Vico'}, {'name': 'Pedrero Yolanda', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quesada, Rocío Vico'}, {'name': 'Zisa Nerina', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quesada, Rocío Vico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quesada, Rocío Vico', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Quesada, Rocío Vico', 'investigatorFullName': 'Rocío Vico Quesada', 'investigatorAffiliation': 'Quesada, Rocío Vico'}}}}