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Completed

NCT Number: NCT03171181

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.

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Key information

Conditions

Inner Ear Disease Behavior Ear Diseases Equilibrium; Disorder, Labyrinth Labyrinth Diseases Otorhinolaryngologic Diseases Spatial Behavior Spatial Navigation

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Ciencias de la Salud

Zaragoza, Aragon, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Balance quality.

    Time frame: 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 outcomes

  1. Dizziness handicap inventory test.

    Time frame: Outcomes were measured in patients at baseline and 3 months.

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

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Collaborators

  • Aragon Institute of Health Sciences

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 31, 2017
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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