search
Back to results

Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

Primary Purpose

Dizziness, Equilibrium; Disorder, Labyrinth, Inner Ear Injury

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vestibular rehabilitation with dynamic posturography
Sponsored by
Eytan A. David
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dizziness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. EA David MD FRCSC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vestibular rehabilitation with dynamic posturography

Arm Description

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

Outcomes

Primary Outcome Measures

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
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)
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)
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
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)

Secondary Outcome Measures

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
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
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)
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)

Full Information

First Posted
April 27, 2021
Last Updated
November 23, 2022
Sponsor
Eytan A. David
search

1. Study Identification

Unique Protocol Identification Number
NCT04875013
Brief Title
Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness
Official Title
Efficacy of Vestibular Rehabilitation Using Computerized Dynamic Posturography With Virtual Reality for Stable Unilateral Vestibular Weakness
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eytan A. David

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness, Equilibrium; Disorder, Labyrinth, Inner Ear Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal cohort; single group assignment; interventional
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular rehabilitation with dynamic posturography
Arm Type
Experimental
Arm Description
12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
Intervention Type
Device
Intervention Name(s)
Vestibular rehabilitation with dynamic posturography
Intervention Description
Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Primary Outcome Measure Information:
Title
Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)
Description
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
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline)
Description
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)
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)
Description
Change in Activities-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate greater confidence in performing activities of daily living)
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline)
Description
Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater perceived fall risk
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline)
Description
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)
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary Outcome Measure Information:
Title
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline)
Description
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
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)
Description
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
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)
Description
Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function)
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline)
Description
Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function)
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Other Pre-specified Outcome Measures:
Title
Adherence to Rehabilitation Protocol
Description
Percentage of subjects that complete 12 sessions
Time Frame
Through study completion, maximum of 12 weeks
Title
Missed Sessions
Description
Mean number of missed and rescheduled rehabilitation sessions
Time Frame
Through study completion, maximum of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eytan David, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. EA David MD FRCSC
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7M 2H5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared.
Citations:
PubMed Identifier
35357406
Citation
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.
Results Reference
derived

Learn more about this trial

Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

We'll reach out to this number within 24 hrs