Back to resultsPosturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit
Primary Purpose
Dizziness, Equilibrium; Disorder, Labyrinth, Inner Ear Injury
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vestibular retraining with dynamic posturography
At-home rehabilitation exercises
Sponsored by
About this trial
This is an interventional treatment trial for Dizziness
Eligibility Criteria
Inclusion Criteria:
- Dizziness handicap inventory score at time of enrolment over 30
Unilateral vestibular weakness confirmed one or more of:
- Videonystagmography showing unilateral weakness to bithermal testing of greater than 25%
- VEMP: IAD asymmetry of greater than 40% for both cVEMP and oVEMP
- VEMP: absence of both ocular and cervical vemp responses in one ear in the context of normal and replicable other ear
- 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 six months
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 dehiscence (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 2
Arm Type
Experimental
Active Comparator
Arm Label
Vestibular retraining with dynamic posturography
At-home rehabilitation exercises
Arm Description
12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
Daily rehabilitation exercises involving nodding and shaking of the head
Outcomes
Primary Outcome Measures
SOT composite score
Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function)
Dizziness Handicap Inventory
Change in Dizziness Handicap Inventory (DHI); 16-30 Points (mild handicap), 32-52 Points (moderate handicap), 54+ Points (severe handicap)
Secondary Outcome Measures
ABC Score
Change in Activity-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate better function)
FES-I score
Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater impairment
SOT condition scores
Change in mean SOT scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function)
LOS directional control
Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function)
LOS excursion
Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function)
DHI component scores
Emotional, physical, and functional components of the DHI score
SOT vestibular contribution
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05115032
Brief Title
Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit
Official Title
Randomized Controlled Trial of Computerized Dynamic Posturography-assisted Vestibular Retraining Compared With At-home Vestibular Rehabilitation Exercises for Stable Unilateral Vestibular Deficit
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)
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 have a higher risk of falling and reduced quality of life. Some individuals can learn to compensate using their vision, their sense of where their limbs are in space, and balance organs that are still intact. Rehabilitation exercises, which typically involve shaking and nodding of the head, are often prescribed for dizzy patients but are not effective for everyone. Our study aims to determine if specific exercises performed on footplate sensors with visual feedback is superior to traditional rehabilitation exercises done at home for improving balance and quality of life.
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, Inner Ear Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized controlled interventional trial; single crossover; single-centre, open label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vestibular retraining 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
Arm Title
At-home rehabilitation exercises
Arm Type
Active Comparator
Arm Description
Daily rehabilitation exercises involving nodding and shaking of the head
Intervention Type
Device
Intervention Name(s)
Vestibular retraining with dynamic posturography
Intervention Description
12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
Intervention Type
Behavioral
Intervention Name(s)
At-home rehabilitation exercises
Intervention Description
6 weeks of daily rehabilitation exercises involving nodding and shaking of the head
Primary Outcome Measure Information:
Title
SOT composite score
Description
Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function)
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
Dizziness Handicap Inventory
Description
Change in Dizziness Handicap Inventory (DHI); 16-30 Points (mild handicap), 32-52 Points (moderate handicap), 54+ Points (severe handicap)
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary Outcome Measure Information:
Title
ABC Score
Description
Change in Activity-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate better function)
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
FES-I score
Description
Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater impairment
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
SOT condition scores
Description
Change in mean SOT scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function)
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
LOS directional control
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
LOS excursion
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
Title
DHI component scores
Description
Emotional, physical, and functional components of the DHI score
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Title
SOT vestibular contribution
Description
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
Time Frame
Through study completion, 12 rehabilitation sessions, an average of 7 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:
Dizziness handicap inventory score at time of enrolment over 30
Unilateral vestibular weakness confirmed one or more of:
Videonystagmography showing unilateral weakness to bithermal testing of greater than 25%
VEMP: IAD asymmetry of greater than 40% for both cVEMP and oVEMP
VEMP: absence of both ocular and cervical vemp responses in one ear in the context of normal and replicable other ear
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 six months
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 dehiscence (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 A 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
Learn more about this trial
Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit
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