Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

Sponsor
Eytan A. David (Other)
Overall Status
Completed
CT.gov ID
NCT04875013
Collaborator
(none)
13
1
1
5.7
2.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Vestibular rehabilitation with dynamic posturography
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Longitudinal cohort; single group assignment; interventionalLongitudinal cohort; single group assignment; interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Vestibular Rehabilitation Using Computerized Dynamic Posturography With Virtual Reality for Stable Unilateral Vestibular Weakness
Actual Study Start Date :
May 10, 2021
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vestibular rehabilitation with dynamic posturography

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

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

Outcome Measures

Primary Outcome Measures

  1. SOT Composite score [Through study completion, 12 rehabilitation sessions, an average of 7 weeks, and at 6 weeks and 3 months after completion of the rehabilitation program]

    Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function)

  2. Dizziness Handicap Inventory [Through study completion, 12 rehabilitation sessions, an average of 7 weeks, and at 6 weeks and 3 months after completion of the rehabilitation program]

    Change in Dizziness Handicap Inventory (DHI); 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap)

  3. ABC Score [Through study completion, 12 rehabilitation sessions, an average of 7 weeks, and at 6 weeks and 3 months after completion of the rehabilitation program]

    Change in Activity-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate better function)

  4. FES-I [Through study completion, 12 rehabilitation sessions, an average of 7 weeks, and at 6 weeks and 3 months after completion of the rehabilitation program]

    Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater impairment

  5. LOS Score [Through study completion, 12 rehabilitation sessions, an average of 7 weeks, and at 6 weeks and 3 months after completion of the rehabilitation program]

    Change in Limits of Stability (LOS) score

Secondary Outcome Measures

  1. SOT condition scores [Through study completion, 12 rehabilitation sessions, an average of 7 weeks, and at 6 weeks and 3 months after completion of the rehabilitation program]

    Change in mean SOT scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function)

  2. SOT vestibular contribution [Through study completion, 12 rehabilitation sessions, an average of 7 weeks, and at 6 weeks and 3 months after completion of the rehabilitation program]

    Change in mean value of SOT condition 5/mean value of SOT conditions 1; measured as a ratio, higher scores indicate a greater vestibular contribution to balance deficit

  3. LOS directional control [Through study completion, 12 rehabilitation sessions, an average of 7 weeks, and at 6 weeks and 3 months after completion of the rehabilitation program]

    Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function)

  4. LOS excursion [Through study completion, 12 rehabilitation sessions, an average of 7 weeks, and at 6 weeks and 3 months after completion of the rehabilitation program]

    Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function)

Other Outcome Measures

  1. Adherence to rehabilitation protocol [Through study completion, maximum of 12 weeks]

    Percentage of subjects that complete 12 sessions

  2. Missed sessions [Through study completion, maximum of 12 weeks]

    Mean number of missed and rescheduled rehabilitation sessions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr. EA David MD FRCSC North Vancouver British Columbia Canada V7M 2H5

Sponsors and Collaborators

  • Eytan A. David

Investigators

  • Principal Investigator: Eytan David, MD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eytan A. David, MD, FRCSC, Clinical Instructor, Dept. of Surgery, University of British Columbia
ClinicalTrials.gov Identifier:
NCT04875013
Other Study ID Numbers:
  • H20-04045
First Posted:
May 6, 2021
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2022