Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit

Dizziness Clinical Trial

Official title:

Randomized Controlled Trial of Computerized Dynamic Posturography-assisted Vestibular Retraining Compared With At-home Vestibular Rehabilitation Exercises for Stable Unilateral Vestibular Deficit

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05115032
• Other study ID #: H21-03343
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• 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 2024
• 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

Related Conditions & MeSH terms

• Dizziness
• Ear Diseases
• Equilibrium; Disorder, Labyrinth
• Inner Ear Disease
• Labyrinth Diseases
• Labyrinthitis

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