Inner Ear DiseaseNCT03171181
Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.
A study testing Vestibular reeducation in people with Inner Ear Disease and Equilibrium; Disorder, Labyrinth, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Motor control includes postural control and voluntary movement. For an optimal motor control it is necessary that brain integrates vestibular, visual and somatosensorial inputs properly, in a nonlinear way. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Inner Ear Disease, Equilibrium; Disorder, Labyrinth, Spatial Navigation
- What is being tested?
- Vestibular reeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to 30 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People diagnosed of UPVD
- Length of process superior to three months
- Normal vision or corrected by lens or glasses.
Who cannot join
- Dizziness or balance alteration due to visual problem or lesion of CNS (central nervous system).
- Balance disturbance due to a locomotor cause
- Balance perturbation next to resolve.
- Sharpening or acute phase os symptoms.
- Difficulties with understanding commands.
Trial locations and contacts
1 site in 1 country.
About this study
Motor control includes postural control and voluntary movement. For an optimal motor control it is necessary that brain integrates vestibular, visual and somatosensorial inputs properly, in a nonlinear way. Vestibular system, as an afferent organ, encodes head position in relation to gravity and changes in its linear and angular acceleration. As vestibular central system, it plays an essential role in motor control and in orientation and spatial memory as well.
When a peripheral vestibular lesion occurs, elaboration, interpretation and processing of inputs are deficient and therefore motor control is altered to a greater or lesser degree. As process progress in time, there is a natural neuroplasticity that facilitates recovery or compensate vestibular function, although sometimes this process is incomplete and requires vestibular reeducation This study aims to assess changes in balance control, orientation and handicap perception in one case group with symptomatic unilateral peripheral vestibular dysfunction, before and after a rehabilitation programme (RV). To compare values obtained at the beginning and at the end of RV to those achieved by control group. Finally, this research aims to analyse evolution of spatial orientation quality in symptomatic and non symptomatic participants.
Read the detailed description
Intervention group: 30 people with a unilateral peripheral vestibular disorder (UPVD). Process lasting more than three months and symptomatic. Aged 18-66 years old.
Control group: 30 participants without UPVD, healthy for the purpose of study. No intervention group: 30 people with a unilateral peripheral vestibular disorder without symptomatology. Both groups also aged 18-66.
Balance quality was registered with static and dynamic posturography. For spatial orientation is was registered Visual vertical and visual orientation perception. Vestibular disability was also assessed. Variables were registered at the beginning and at the end of a vestibular reeducation in UPVD participants. Vestibular reeducation consisted of 10 sessions of vestibular rehabilitation using dynamic posturography and visual reeducation. Duration of each session: 40 minutes. Twice a week.
The aim is to compare data before and after intervention with those obtained in compensated patients and control group.
- Being tested
- Vestibular reeducation
- Keywords
- Spatial cognition, vestibular system, motor control
- Medical subject headings
- Labyrinth Diseases, Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular reeducationOther
Balance quality was registered with static and dynamic posturography. For spatial orientation is was registered Visual vertical and visual orientation perception. Vestibular disability was also assessed. Variables were registered at the beginning and at the end of a vestibular rehabilitation in UPVD participants. Vestibular rehabilitation consisted of 10 sessions of vestibular rehabilitation using dynamic posturography and visual reeducation. Duration of each session: 40 minutes. Twice a week.
| Study group | Role | What they receive |
|---|---|---|
| UPVD non compensated | Experimental | Intervention group: 30 participants with unilateral peripheral vestibular disorders. Exposed to vestibular reeducation. Receives: Other: Vestibular reeducation |
| control group | No intervention | Control group, to obtain reference values. |
| UPVD compensated | No intervention | Registered spatial orientation in a group of 30 participants with compensated lesion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Visual vertical and visual orientation degrees at baseline and before treatment.
Visual vertical and visual orientation were measured with bucket test
Measured: Outcomes were measured in patients at baseline and 3 months. Control group and compensated group were registered at baseline.
Secondary outcomes (1)
Balance quality.
Balance quality was obtained from static and dynamic posturography
Measured: Outcomes were measured in patients at baseline and 3 months. Control group was registered at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study startNov 2013
- Primary completionMar 2015
- Study completion30 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inner Ear DiseaseStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Longitudinal case-control study. Accidental sampling. Single - centre study (Hospital Universitario Miguel Servet, Zaragoza. Spain)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- Aragon Institute of Health Sciences
- Responsible party
- Principal investigator, Pilar Dominguez-Olivan, Universidad de Zaragoza
- Investigators
- Ana Bengoetxea-Arrese, PhD, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171181
- Sponsor's protocol ID
- Universidad de Zaragoza
- Status last verified
- May 2018
- First submitted
- 24 May 2017
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data are: age, sex, side of lesion and pathology. Patients are coded, so name is only known by person who makes clinical registration.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.
- ClinicalTrials.gov ID
- NCT03171181
- Acronym / sponsor ID
- Universidad de Zaragoza
- Keywords
- Spatial cognition, vestibular system, motor control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- Aragon Institute of Health Sciences
- Study start
- Nov 2013 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- 30 Aug 2015 (actual)
- First posted
- 31 May 2017 (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.
Motor control includes postural control and voluntary movement. For an optimal motor control it is necessary that brain integrates vestibular, visual and somatosensorial inputs properly, in a nonlinear way. Vestibular system, as an afferent organ, encodes head position in relation to gravity and changes in its linear and angular acceleration. As vestibular central system, it plays an essential role in motor control and in orientation and spatial memory as well.
When a peripheral vestibular lesion occurs, elaboration, interpretation and processing of inputs are deficient and therefore motor control is altered to a greater or lesser degree. As process progress in time, there is a natural neuroplasticity that facilitates recovery or compensate vestibular function, although sometimes this process is incomplete and requires vestibular reeducation This study aims to assess changes in balance control, orientation and handicap perception in one case group with symptomatic unilateral peripheral vestibular dysfunction, before and after a rehabilitation programme (RV). To compare values obtained at the beginning and at the end of RV to those achieved by control group. Finally, this research aims to analyse evolution of spatial orientation quality in symptomatic and non symptomatic participants.
Detailed description
Intervention group: 30 people with a unilateral peripheral vestibular disorder (UPVD). Process lasting more than three months and symptomatic. Aged 18-66 years old.
Control group: 30 participants without UPVD, healthy for the purpose of study. No intervention group: 30 people with a unilateral peripheral vestibular disorder without symptomatology. Both groups also aged 18-66.
Balance quality was registered with static and dynamic posturography. For spatial orientation is was registered Visual vertical and visual orientation perception. Vestibular disability was also assessed. Variables were registered at the beginning and at the end of a vestibular reeducation in UPVD participants. Vestibular reeducation consisted of 10 sessions of vestibular rehabilitation using dynamic posturography and visual reeducation. Duration of each session: 40 minutes. Twice a week.
The aim is to compare data before and after intervention with those obtained in compensated patients and control group.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Longitudinal case-control study. Accidental sampling. Single - centre study (Hospital Universitario Miguel Servet, Zaragoza. Spain)
| Arm | Type | Receives |
|---|---|---|
| UPVD non compensated | Experimental | Other: Vestibular reeducationIntervention group: 30 participants with unilateral peripheral vestibular disorders. Exposed to vestibular reeducation. |
| control group | No intervention | –Control group, to obtain reference values. |
| UPVD compensated | No intervention | –Registered spatial orientation in a group of 30 participants with compensated lesion. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People diagnosed of UPVD
- Length of process superior to three months
- Normal vision or corrected by lens or glasses.
Key exclusion criteria (5 listed)
- Dizziness or balance alteration due to visual problem or lesion of CNS (central nervous system).
- Balance disturbance due to a locomotor cause
- Balance perturbation next to resolve.
- Sharpening or acute phase os symptoms.
- Difficulties with understanding commands.
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 |
|---|---|---|
| Vestibular reeducationBalance quality was registered with static and dynamic posturography. For spatial orientation is was registered Visual vertical and visual orientation perception. Vestibular disability was also assessed. Variables were registered at the beginning and at the end of a vestibular rehabilitation in UPVD participants. Vestibular rehabilitation consisted of 10 sessions of vestibular rehabilitation using dynamic posturography and visual reeducation. Duration of each session: 40 minutes. Twice a week. | Other | UPVD non compensated |
Primary outcome
Changes in Visual vertical and visual orientation degrees at baseline and before treatment.
Time frame: Outcomes were measured in patients at baseline and 3 months. Control group and compensated group were registered at baseline.
Visual vertical and visual orientation were measured with bucket test
1 secondary outcome
Balance quality.
Time frame: Outcomes were measured in patients at baseline and 3 months. Control group was registered at baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: Yes. Individual participant data are: age, sex, side of lesion and pathology. Patients are coded, so name is only known by person who makes clinical registration.
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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. This study is not recruiting at the moment.
Ana Bengoetxea-Arrese, PhD principal investigator
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular reeducation in people with Inner Ear Disease and Equilibrium; Disorder, Labyrinth, run by Universidad de Zaragoza at 1 site in Spain.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 May 2018. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Visual vertical and visual orientation degrees at baseline and before treatment. (time frame: Outcomes were measured in patients at baseline and 3 months. Control group and compensated group were registered at baseline.). 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 11 May 2018.