Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.

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.

Study Overview

• Status: Completed
• Conditions: Equilibrium; Disorder, Labyrinth; Spatial Navigation; Inner Ear Disease
• Intervention / Treatment: Other: Vestibular reeducation

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Facultad de Ciencias de la Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: UPVD non compensated; Intervention group: 30 participants with unilateral peripheral vestibular disorders. Exposed to vestibular reeducation.	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.
NO_INTERVENTION: control group; Control group, to obtain reference values.
NO_INTERVENTION: UPVD compensated; Registered spatial orientation in a group of 30 participants with compensated lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza
• Collaborators: Aragon Institute of Health Sciences
• Investigators: Principal Investigator: Ana Bengoetxea-Arrese, PhD, Université libre de Bruxelles

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2013
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): August 30, 2015

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (ACTUAL): May 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Spatial cognition, vestibular system, motor control
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Otitis; Ear Diseases; Labyrinthitis; Labyrinth Diseases
• Other Study ID Numbers: Universidad de Zaragoza

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 2014-2018
• IPD Sharing Access Criteria: affiliation code. The rest of information is shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No