Vestibular DisorderNCT07079488
Vestibular Function and Motor Development in Small Children
A study testing Motor proficiency scales in people with Vestibular Disorder, run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- Motor proficiency scales
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- vestibular impairment normal vestibular function -
Who cannot join
- children unable to be tested with chield-friendly vestibular testing
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Motor Development in Infants and Toddlers Affected by Vestibular Impairment
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.
- Conditions
- Vestibular Disorder
- Being tested
- Motor proficiency scales
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor proficiency scalesDiagnostic test
AIMS, PDMS-2, HINE
| Study group | Role | What they receive |
|---|---|---|
| vestibular impairment | Other | Not described Receives: Diagnostic Test: Motor proficiency scales |
| control subject | Other | Not described Receives: Diagnostic Test: Motor proficiency scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peabody Developmental Motor Scales II
Pathological motor patterns
Measured: at enrollment and at 6 months
Alberta Infant Motor Scales
Pathological motor patterns
Measured: at enrollment and at 6 months
Hammersmith Infant Neurological Examination checklist
Pathological motor patterns
Measured: at enrollment and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Nov 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Luca Verrecchia, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079488
- Sponsor's protocol ID
- K2023-7366
- Status last verified
- Jul 2025
- First submitted
- 12 Oct 2023
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Development in Infants and Toddlers Affected by Vestibular Impairment
- ClinicalTrials.gov ID
- NCT07079488
- Acronym / sponsor ID
- K2023-7366
- Conditions
- Vestibular Disorder
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vestibular impairment | Other | Diagnostic Test: Motor proficiency scales |
| control subject | Other | Diagnostic Test: Motor proficiency scales |
Who may qualify
- Ages
- 5 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- vestibular impairment normal vestibular function -
Key exclusion criteria (2 listed)
- children unable to be tested with chield-friendly vestibular testing
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor proficiency scalesAIMS, PDMS-2, HINE | Diagnostic test | control subject, vestibular impairment |
Primary outcome
Peabody Developmental Motor Scales II
Time frame: at enrollment and at 6 months
Pathological motor patterns
Alberta Infant Motor Scales
Time frame: at enrollment and at 6 months
Pathological motor patterns
Hammersmith Infant Neurological Examination checklist
Time frame: at enrollment and at 6 months
Pathological motor patterns
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor proficiency scales in people with Vestibular Disorder, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peabody Developmental Motor Scales II (time frame: at enrollment and at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.