Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

Not Applicable

Completed

Conditions: Dizziness
Equilibrium; Disorder, Labyrinth
Inner Ear Injury

Interventions: Device: Vestibular rehabilitation with dynamic posturography

Registration Number: NCT04875013

Lead Sponsor: Eytan A. David

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 13

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vestibular rehabilitation with dynamic posturography	Vestibular rehabilitation with dynamic posturography	12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback

Primary Outcome Measures

Name	Time	Method
Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in composite score of Sensory Organization Test (SOT) (Scores from 0-100; higher scores indicate better function); Lower scores indicate larger amount of sway Calculated as a composite of the 6 individual conditions of the SOT: 1. Eyes open on firm surface 2. Eyes closed on firm surface 3. Eyes open with sway referenced visual 4. Eyes open on sway referenced support surface 5. Eyes close on sway referenced support surfrace 6. Eyes open on sway referenced support surface and visual
Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in Dizziness Handicap Inventory (DHI); scale from 0-100; higher scores indicate greater disability; 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap)
Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in Activities-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate greater confidence in performing activities of daily living)
Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater perceived fall risk
Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in endpoint excursion and maximum excursion functional stability region area, calculated from Limits of Stability (LOS) score Higher score indicates an ability to volitionally lean to larger angles. 100% of theoretical maximum in all directions would give an area of 28284. LOS excursion scores were calculated by the instrument software, from which we calculated the area of the endpoint excursion functional stability region (the sum of areas between adjacent Endpoint Excursion limits) and the area of the maximum excursion functional stability region (the sum of areas between adjacent Maximum Excursion limits) using published methods (Alvarez-Otero R, Perez-Fernandez N. The limits of stability in patients with unilateral vestibulopathy. Acta Oto-laryngol. 2017;137(10):1-6. doi:10.1080/00016489.2017.1339326)

Secondary Outcome Measures

Name	Time	Method
Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in mean value of Sensory Organization Test condition 5/mean value of SOT conditions 1; measured as a ratio, higher scores indicate a greater vestibular contribution to balance deficit
Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function)
Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function)
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in mean Sensory Organization Test Scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function) The 6 conditions are: 1. Eyes open on firm surface 2. Eyes closed on firm surface 3. Eyes open with sway referenced visual 4. Eyes open on sway referenced support surface 5. Eyes close on sway referenced support surfrace 6. Eyes open on sway referenced support surface and visual