NCT07079488

Brief Summary

Infants and toddlers with and without vestibular impairment will be tested blinded by pediatric physiotherapist with different age adequate motor scales in order to find out pathological motor patterns specifically associated to vestibular impairment.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

October 12, 2023

Last Update Submit

July 22, 2025

Conditions

Vestibular Disorder

Outcome Measures

Primary Outcomes (3)

  • Peabody Developmental Motor Scales II

    Pathological motor patterns

    at enrollment and at 6 months

  • Alberta Infant Motor Scales

    Pathological motor patterns

    at enrollment and at 6 months

  • Hammersmith Infant Neurological Examination checklist

    Pathological motor patterns

    at enrollment and at 6 months

Study Arms (2)

vestibular impairment

OTHER
Diagnostic Test: Motor proficiency scales

control subject

OTHER
Diagnostic Test: Motor proficiency scales

Interventions

Motor proficiency scalesDIAGNOSTIC_TEST

AIMS, PDMS-2, HINE

control subjectvestibular impairment

Eligibility Criteria

Age5 Months - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • vestibular impairment normal vestibular function -

You may not qualify if:

  • children unable to be tested with chield-friendly vestibular testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Univerisity Hospital

Stockholm, 14157, Sweden

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2023

First Posted

July 23, 2025

Study Start

November 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations

SE(1)