Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.

Sponsor
Universidad de Zaragoza (Other)
Overall Status
Completed
CT.gov ID
NCT03171181
Collaborator
Aragon Institute of Health Sciences (Other)
90
1
3
21.9
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Vestibular reeducation
N/A

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

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Longitudinal case-control study. Accidental sampling. Single - centre study (Hospital Universitario Miguel Servet, Zaragoza. Spain)Longitudinal case-control study. Accidental sampling. Single - centre study (Hospital Universitario Miguel Servet, Zaragoza. Spain)
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.
Actual Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Aug 30, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in Visual vertical and visual orientation degrees at baseline and before treatment. [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

Secondary Outcome Measures

  1. Balance quality. [Outcomes were measured in patients at baseline and 3 months. Control group was registered at baseline.]

    Balance quality was obtained from static and dynamic posturography

Other Outcome Measures

  1. Dizziness handicap inventory test. [Outcomes were measured in patients at baseline and 3 months.]

    Quality of life was registered with Dizziness handicap inventory test (DHI).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 66 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Facultad de Ciencias de la Salud Zaragoza Aragon Spain 50009

Sponsors and Collaborators

  • Universidad de Zaragoza
  • Aragon Institute of Health Sciences

Investigators

  • Principal Investigator: Ana Bengoetxea-Arrese, PhD, Université Libre de Bruxelles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pilar Dominguez-Olivan, Ph D. Physical Therapist., Universidad de Zaragoza
ClinicalTrials.gov Identifier:
NCT03171181
Other Study ID Numbers:
  • Universidad de Zaragoza
First Posted:
May 31, 2017
Last Update Posted:
May 11, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pilar Dominguez-Olivan, Ph D. Physical Therapist., Universidad de Zaragoza
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2018