Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

Dizziness Clinical Trial

Official title:

Efficacy of Vestibular Rehabilitation Using Computerized Dynamic Posturography With Virtual Reality for Stable Unilateral Vestibular Weakness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875013
• Other study ID #: H20-04045
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

People that have difficulty with balance, such as those with damage to their inner ear, have a higher risk of falling, which may lead to anxiety and reduced quality of life. Some individuals that have lost part of their sense of balance can learn to compensate using information from their vision, their sense of where their limbs are in space, and from other balance organs that are still intact. Our study aims to determine if virtual reality used together with information from footplate sensors can be used to train people with balance problems to compensate for their inner ear deficits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult Age 18-80
• Unilateral vestibular weakness confirmed one or more of:
• Videonystagmography
• VEMP
• Or unilateral vestibular weakness idiopathic, not yet diagnosed (NYD)
• Persistent imbalance following diagnosis of resolved benign paroxysmal positional vertigo (BPPV)
• Symptomatic
• Long-standing/persistent symptoms greater than one year

Exclusion Criteria:

• Orthopedic deficit (eg. lower body joint dysfunction or lower joint replacement)
• Neurological deficit or proprioception deficit
• Diabetes
• Poor vision or blindness
• Fluctuating vestibular symptoms, or condition known to fluctuate eg. Menière's disease, perilymphatic fistula (PLF) or superior canal deshicsence (SDCS)
• Active benign paroxysmal positional vertigo (BPPV)
• Undergoing treatment which may affect balance or ability to stand
• Cognitive impairment that prevents understanding and responding to instructions required to complete the study
• Inability to provide informed consent

Related Conditions & MeSH terms

• Dizziness
• Equilibrium; Disorder, Labyrinth

Intervention

Device:
• Vestibular rehabilitation with dynamic posturography
Rehabilitation exercises guided by an interactive display and measured by a footplate sensor

Locations

Country	Name	City	State
Canada	Dr. EA David MD FRCSC	North Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eytan A. David

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to Rehabilitation Protocol	Percentage of subjects that complete 12 sessions	Through study completion, maximum of 12 weeks
Other	Missed Sessions	Mean number of missed and rescheduled rehabilitation sessions	Through study completion, maximum of 12 weeks
Primary	Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)	Change in composite score of Sensory Organization Test (SOT) (Scores from 0-100; higher scores indicate better function); Lower scores indicate larger amount of sway; Calculated as a composite of the 6 individual conditions of the SOT: Eyes open on firm surface; Eyes closed on firm surface; Eyes open with sway referenced visual; Eyes open on sway referenced support surface; Eyes close on sway referenced support surfrace; Eyes open on sway referenced support surface and visual	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Primary	Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline)	Change in Dizziness Handicap Inventory (DHI); scale from 0-100; higher scores indicate greater disability; 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Primary	Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)	Change in Activities-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate greater confidence in performing activities of daily living)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Primary	Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline)	Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater perceived fall risk	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Primary	Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline)	Change in endpoint excursion and maximum excursion functional stability region area, calculated from Limits of Stability (LOS) score Higher score indicates an ability to volitionally lean to larger angles. 100% of theoretical maximum in all directions would give an area of 28284.; LOS excursion scores were calculated by the instrument software, from which we calculated the area of the endpoint excursion functional stability region (the sum of areas between adjacent Endpoint Excursion limits) and the area of the maximum excursion functional stability region (the sum of areas between adjacent Maximum Excursion limits) using published methods (Alvarez-Otero R, Perez-Fernandez N. The limits of stability in patients with unilateral vestibulopathy. Acta Oto-laryngol. 2017;137(10):1-6. doi:10.1080/00016489.2017.1339326)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary	Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline)	Change in mean Sensory Organization Test Scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function); The 6 conditions are: Eyes open on firm surface; Eyes closed on firm surface; Eyes open with sway referenced visual; Eyes open on sway referenced support surface; Eyes close on sway referenced support surfrace; Eyes open on sway referenced support surface and visual	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary	Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)	Change in mean value of Sensory Organization Test condition 5/mean value of SOT conditions 1; measured as a ratio, higher scores indicate a greater vestibular contribution to balance deficit	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary	Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)	Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary	Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline)	Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks