NCT04788134

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 4, 2021

Last Update Submit

March 8, 2021

Conditions

Keywords

vestibular function testsnystagmus, physiologicadultadolescent

Outcome Measures

Primary Outcomes (1)

  • Duration of vestibular-ocular reflex after the administration of nystagmus post-rotatory test in adolescent and adult population

    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.

    End of the nystagmus post rotatory test and end of the vestibular-ocular reflex

Interventions

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.

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People over 13 years, that lives in the north, middle and south of Spain, and meet the selection criteria.

You may qualify if:

  • People over 13 years of age.
  • Spanish-speaking population.
  • Signature of the informed consent.

You may not qualify if:

  • Diagnosis of a neurodevelopmental or neurological disorder.
  • Being in occupational therapeutic treatment for balance or vestibular problems.
  • Practice of sports in one previous hour.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Nystagmus, Pathologic

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Vico Rocío

    Quesada, Rocío Vico

    PRINCIPAL INVESTIGATOR
  • Pedrero Yolanda

    Quesada, Rocío Vico

    PRINCIPAL INVESTIGATOR
  • Zisa Nerina

    Quesada, Rocío Vico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Quesada, Rocío Vico

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 9, 2021

Study Start

April 1, 2021

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share