An interventional study of Vestibular reeducation in Inner Ear Disease, Equilibrium; Disorder, Labyrinth and Spatial Navigation, sponsored by Universidad de Zaragoza. Completed at 1 site in Spain. Open to participants aged 18 Years to 66 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-11.
Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Basic science
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.
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.
21 studies on the registry are indexed under Labyrinth Diseases; 8 are open to participants now.
This study's enrollment of 90 is above the median of 37 across 16 interventional studies indexed under Labyrinth Diseases.
Browse Labyrinth Diseases studies →Universidad de Zaragoza is the lead sponsor of 111 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Intervention group: 30 participants with unilateral peripheral vestibular disorders. Exposed to vestibular reeducation.
Other: Vestibular reeducation
Control group, to obtain reference values.
Registered spatial orientation in a group of 30 participants with compensated lesion.
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.
Changes in Visual vertical and visual orientation degrees at baseline and before treatment.
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.
Balance quality.
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.
Dizziness handicap inventory test.
Quality of life was registered with Dizziness handicap inventory test (DHI).
Time frame: Outcomes were measured in patients at baseline and 3 months.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 2014-2018
Access criteria: affiliation code. The rest of information is shared.
No publications or documents are linked to this record.
Ran from Nov 2013 to primary completion in Mar 2015, 16 months.
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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