Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.

NCT ID: NCT03171181

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-08-30

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.

Conditions

Inner Ear Disease; Equilibrium; Disorder, Labyrinth; Spatial Navigation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

UPVD non compensated

Intervention group: 30 participants with unilateral peripheral vestibular disorders. Exposed to vestibular reeducation.

Group Type: EXPERIMENTAL

Vestibular reeducation

Intervention Type: OTHER

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.

control group

Control group, to obtain reference values.

Group Type: NO_INTERVENTION

No interventions assigned to this group

UPVD compensated

Registered spatial orientation in a group of 30 participants with compensated lesion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vestibular reeducation

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aragon Institute of Health Sciences

OTHER

Sponsor Role: collaborator

Universidad de Zaragoza

OTHER

Sponsor Role: lead

Responsible Party

Pilar Dominguez-Olivan

Ph D. Physical Therapist.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Bengoetxea-Arrese, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Libre de Bruxelles

Locations

Facultad de Ciencias de la Salud

Zaragoza, Aragon, Spain

Countries

Spain

Other Identifiers

Universidad de Zaragoza

Identifier Type: -

Identifier Source: org_study_id