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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05115032
Other study ID # H21-03343
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 17, 2022
Est. completion date December 2023

Study information

Verified date May 2023
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 37
Est. completion date December 2023
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Device:
Vestibular retraining with dynamic posturography
12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback
Behavioral:
At-home rehabilitation exercises
6 weeks of daily rehabilitation exercises involving nodding and shaking of the head

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
Primary SOT composite score Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function) Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Primary Dizziness Handicap Inventory Change in Dizziness Handicap Inventory (DHI); 16-30 Points (mild handicap), 32-52 Points (moderate handicap), 54+ Points (severe handicap) Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary ABC Score Change in Activity-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate better function) Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary FES-I score Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater impairment Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary SOT condition scores Change in mean SOT scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function) Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary 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) Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary LOS excursion 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
Secondary DHI component scores Emotional, physical, and functional components of the DHI score Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary 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 Through study completion, 12 rehabilitation sessions, an average of 7 weeks
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