Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit

NCT05115032 | Completed FDA Device

• 1 other identifier: H21-03343
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Dizziness; Equilibrium; Disorder, Labyrinth; Inner Ear Injury; Inner Ear Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• ABC Score

  Through study completion, 12 rehabilitation sessions, an average of 7 weeks

• FES-I score

  Through study completion, 12 rehabilitation sessions, an average of 7 weeks

• SOT condition scores

  Through study completion, 12 rehabilitation sessions, an average of 7 weeks

• LOS directional control

  Through study completion, 12 rehabilitation sessions, an average of 7 weeks

• LOS excursion

  Through study completion, 12 rehabilitation sessions, an average of 7 weeks

Study Arms (2)

Vestibular retraining with dynamic posturography

EXPERIMENTAL

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

Device: Vestibular retraining with dynamic posturography

At-home rehabilitation exercises

ACTIVE COMPARATOR

Daily rehabilitation exercises involving nodding and shaking of the head

Behavioral: At-home rehabilitation exercises

Interventions

Vestibular retraining with dynamic posturography DEVICE

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

Vestibular retraining with dynamic posturography

At-home rehabilitation exercises BEHAVIORAL

6 weeks of daily rehabilitation exercises involving nodding and shaking of the head

At-home rehabilitation exercises

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eytan A. David: lead

Study Sites (1)

Dr. EA David MD FRCSC

North Vancouver, British Columbia, V7M 2H5, Canada

Location

Related Publications (1)

• David EA, Shahnaz N, Wiseman I, David Y, Cochrane CL. Vestibular Rehabilitation Using Dynamic Posturography: Functional Stability and Fall Risk Outcomes From a Randomized Trial. Otolaryngol Head Neck Surg. 2025 Sep;173(3):713-723. doi: 10.1002/ohn.1302. Epub 2025 Jul 7.

  PMID: 40624853 DERIVED

MeSH Terms

Conditions

Dizziness; Labyrinth Diseases

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Eytan A David, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, FRCSC, Clinical Instructor, Dept. of Surgery

Model Details: Randomized controlled interventional trial; single crossover; single-centre, open label

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: January 17, 2022
• Primary Completion: December 15, 2022
• Study Completion: April 19, 2023
• Last Updated: April 10, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)