Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

NCT04875013 | Completed Results FDA Device

• 1 other identifier: H20-04045
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dizziness; Equilibrium; Disorder, Labyrinth; Inner Ear Injury

Outcome Measures

Primary Outcomes (5)

• 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: 1. Eyes open on firm surface 2. Eyes closed on firm surface 3. Eyes open with sway referenced visual 4. Eyes open on sway referenced support surface 5. Eyes close on sway referenced support surfrace 6. Eyes open on sway referenced support surface and visual

  Through study completion, 12 rehabilitation sessions, an average of 7 weeks

• 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

• 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

• 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

• 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 Outcomes (4)

• Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline)

  Through study completion, 12 rehabilitation sessions, an average of 7 weeks

• Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)

  Through study completion, 12 rehabilitation sessions, an average of 7 weeks

• Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)

  Through study completion, 12 rehabilitation sessions, an average of 7 weeks

• Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline)

  Through study completion, 12 rehabilitation sessions, an average of 7 weeks

Other Outcomes (2)

• Adherence to Rehabilitation Protocol

  Through study completion, maximum of 12 weeks

• Missed Sessions

  Through study completion, maximum of 12 weeks

Study Arms (1)

Vestibular rehabilitation with dynamic posturography

EXPERIMENTAL

12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback

Device: Vestibular rehabilitation with dynamic posturography

Interventions

Vestibular rehabilitation with dynamic posturography DEVICE

Rehabilitation exercises guided by an interactive display and measured by a footplate sensor

Vestibular rehabilitation with dynamic posturography

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eytan A. David: lead

Study Sites (1)

Dr. EA David MD FRCSC

North Vancouver, British Columbia, V7M 2H5, Canada

Location

Related Publications (4)

• David EA, Shahnaz N. Posturographic sensory ratios provide evidence for neuroplasticity after computerized vestibular rehabilitation therapy in a single group interventional trial. J Neuroeng Rehabil. 2025 Apr 11;22(1):81. doi: 10.1186/s12984-025-01608-w.

  PMID: 40217271 DERIVED

• David EA, Shahnaz N, Wiseman I, David Y, Cochrane CL. Computerized Dynamic Posturography-Guided Vestibular Rehabilitation Improves Vestibular Sensory Ratios. Ear Nose Throat J. 2025 Mar 12:1455613251321978. doi: 10.1177/01455613251321978. Online ahead of print.

  PMID: 40072844 DERIVED

• David EA, Shahnaz N. Dynamic posturography after computerized vestibular retraining for stable unilateral vestibular deficits. Acta Otolaryngol. 2023 May;143(5):396-401. doi: 10.1080/00016489.2023.2208615. Epub 2023 May 12.

  PMID: 37173291 DERIVED

• David EA, Shahnaz N. Patient-Reported Disability After Computerized Posturographic Vestibular Retraining for Stable Unilateral Vestibular Deficit. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):426-433. doi: 10.1001/jamaoto.2022.0167.

  PMID: 35357406 DERIVED

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Eytan David
• Organization: DR. EYTAN A. DAVID, MD, Otolaryngologist

dr.david@shaw.ca

(604) 988-0598

Study Officials

• Eytan David, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, FRCSC, Clinical Instructor, Dept. of Surgery

Model Details: Longitudinal cohort; single group assignment; interventional

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 6, 2021
• Study Start: May 10, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: December 20, 2022
• Results First Posted: December 20, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)