Clinical trial NCT03171181: Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.
Official title: Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inner Ear Disease
Equilibrium; Disorder, Labyrinth
Spatial Navigation
Keywords: Spatial cognition, vestibular system, motor control
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: Aragon Institute of Health Sciences
First posted: 2017-05-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal case-control study. Accidental sampling. Single - centre study (Hospital Universitario Miguel Servet, Zaragoza. Spain)
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* People diagnosed of UPVD
* Length of process superior to three months
* Normal vision or corrected by lens or glasses.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Visual vertical and visual orientation degrees at baseline and before treatment.
timeFrame: Outcomes were measured in patients at baseline and 3 months. Control group and compensated group were registered at baseline.
Secondary outcomes:
measure: Balance quality.
timeFrame: Outcomes were measured in patients at baseline and 3 months. Control group was registered at baseline.
Other outcomes:
measure: Dizziness handicap inventory test.
timeFrame: Outcomes were measured in patients at baseline and 3 months.
Locations:
city: Zaragoza
country: Spain
facility: Facultad de Ciencias de la Salud
state: Aragon
Study officials:
affiliation: Université Libre de Bruxelles
name: Ana Bengoetxea-Arrese, PhD
role: PRINCIPAL_INVESTIGATOR
References: