Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.

Inner Ear Disease Clinical Trial

Official title:

Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171181
• Other study ID #: Universidad de Zaragoza
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: August 30, 2015

Study information

• Verified date: May 2018
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 30, 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ear Diseases
• Equilibrium; Disorder, Labyrinth
• Inner Ear Disease
• Labyrinth Diseases
• Labyrinthitis
• Spatial Navigation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Facultad de Ciencias de la Salud	Zaragoza	Aragon

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Zaragoza	Aragon Institute of Health Sciences

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dizziness handicap inventory test.	Quality of life was registered with Dizziness handicap inventory test (DHI).	Outcomes were measured in patients at baseline and 3 months.
Primary	Changes in Visual vertical and visual orientation degrees at baseline and before treatment.	Visual vertical and visual orientation were measured with bucket test	Outcomes were measured in patients at baseline and 3 months. Control group and compensated group were registered at baseline.
Secondary	Balance quality.	Balance quality was obtained from static and dynamic posturography	Outcomes were measured in patients at baseline and 3 months. Control group was registered at baseline.