Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.
Primary Purpose
Inner Ear Disease, Equilibrium; Disorder, Labyrinth, Spatial Navigation
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vestibular reeducation
Sponsored by
About this trial
This is an interventional basic science trial for Inner Ear Disease focused on measuring Spatial cognition, vestibular system, motor control
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.
Sites / Locations
- Facultad de Ciencias de la Salud
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
UPVD non compensated
control group
UPVD compensated
Arm Description
Intervention group: 30 participants with unilateral peripheral vestibular disorders. Exposed to vestibular reeducation.
Control group, to obtain reference values.
Registered spatial orientation in a group of 30 participants with compensated lesion.
Outcomes
Primary Outcome Measures
Changes in Visual vertical and visual orientation degrees at baseline and before treatment.
Visual vertical and visual orientation were measured with bucket test
Secondary Outcome Measures
Balance quality.
Balance quality was obtained from static and dynamic posturography
Full Information
NCT ID
NCT03171181
First Posted
May 24, 2017
Last Updated
May 3, 2018
Sponsor
Universidad de Zaragoza
Collaborators
Aragon Institute of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03171181
Brief Title
Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.
Official Title
Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
August 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
Collaborators
Aragon Institute of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inner Ear Disease, Equilibrium; Disorder, Labyrinth, Spatial Navigation
Keywords
Spatial cognition, vestibular system, motor control
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal case-control study. Accidental sampling. Single - centre study (Hospital Universitario Miguel Servet, Zaragoza. Spain)
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UPVD non compensated
Arm Type
Experimental
Arm Description
Intervention group: 30 participants with unilateral peripheral vestibular disorders. Exposed to vestibular reeducation.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Control group, to obtain reference values.
Arm Title
UPVD compensated
Arm Type
No Intervention
Arm Description
Registered spatial orientation in a group of 30 participants with compensated lesion.
Intervention Type
Other
Intervention Name(s)
Vestibular reeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Visual vertical and visual orientation degrees at baseline and before treatment.
Description
Visual vertical and visual orientation were measured with bucket test
Time Frame
Outcomes were measured in patients at baseline and 3 months. Control group and compensated group were registered at baseline.
Secondary Outcome Measure Information:
Title
Balance quality.
Description
Balance quality was obtained from static and dynamic posturography
Time Frame
Outcomes were measured in patients at baseline and 3 months. Control group was registered at baseline.
Other Pre-specified Outcome Measures:
Title
Dizziness handicap inventory test.
Description
Quality of life was registered with Dizziness handicap inventory test (DHI).
Time Frame
Outcomes were measured in patients at baseline and 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Bengoetxea-Arrese, PhD
Organizational Affiliation
Université Libre de Bruxelles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Ciencias de la Salud
City
Zaragoza
State/Province
Aragon
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.
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