Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.

NCT03171181 | Completed DMC

• 1 other identifier: Universidad de Zaragoza
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Spatial cognition, vestibular system, motor control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Balance quality.

  Outcomes were measured in patients at baseline and 3 months. Control group was registered at baseline.

Other Outcomes (1)

• Dizziness handicap inventory test.

  Outcomes were measured in patients at baseline and 3 months.

Study Arms (3)

UPVD non compensated

EXPERIMENTAL

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

Other: Vestibular reeducation

control group

NO INTERVENTION

Control group, to obtain reference values.

UPVD compensated

NO INTERVENTION

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

Interventions

Vestibular reeducation 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.

UPVD non compensated

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People diagnosed of UPVD
• Length of process superior to three months
• Normal vision or corrected by lens or glasses.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Aragon Institute of Health Sciences: collaborator

Study Sites (1)

Facultad de Ciencias de la Salud

Zaragoza, Aragon, 50009, Spain

Location

MeSH Terms

Conditions

Labyrinth Diseases; Spatial Navigation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Spatial Behavior; Behavior

Study Officials

• Ana Bengoetxea-Arrese, PhD

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D. Physical Therapist.

Model Details: Longitudinal case-control study. Accidental sampling. Single - centre study (Hospital Universitario Miguel Servet, Zaragoza. Spain)

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 31, 2017
• Study Start: November 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: August 30, 2015
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2014-2018
• Access Criteria: affiliation code. The rest of information is shared.

Locations

ES (1)