Trial Outcomes & Findings for Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness (NCT NCT04875013)

NCT ID: NCT04875013

Last Updated: 2022-12-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
• Results posted on: 2022-12-20

Participant Flow

Participant milestones

Measure	Vestibular Rehabilitation With Dynamic Posturography 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Overall Study STARTED	13
Overall Study Post-treatment Assessment	13
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Age, Continuous	51 years n=13 Participants
Sex: Female, Male Female	5 Participants n=13 Participants
Sex: Female, Male Male	8 Participants n=13 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)	8.8 SOT composite score Interval 0.6 to 19.1

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline)	-16 score on a scale Interval -20.0 to 2.0

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)	11.87 score on a scale Interval 0.0 to 17.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline)	-9 score on a scale Interval -14.0 to 1.0

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline) Endpoint excursion functional stability region	6226 units on a scale Interval 24.0 to 14547.0
Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline) Maximum excursion functional stability region	9802 units on a scale Interval 2248.0 to 21168.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline) SOT condition 1	0.6 score on a scale Interval -1.5 to 4.3
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline) SOT condition 2	-1.8 score on a scale Interval -4.2 to 2.0
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline) SOT condition 3	-1.6 score on a scale Interval -3.2 to 2.6
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline) SOT condition 4	13.9 score on a scale Interval 3.0 to 27.8
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline) SOT condition 5	11.1 score on a scale Interval 1.6 to 23.4
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline) SOT condition 6	13.1 score on a scale Interval 2.9 to 34.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)	0.10 ratio of scores on a scale Interval -0.06 to 0.25

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)	41.1 Directional control % Interval 5.9 to 79.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline) Endpoint excursion	36 excursion as % of limit of stability Interval 2.0 to 51.0
Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline) Maximum excursion	47 excursion as % of limit of stability Interval 5.9 to 79.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, maximum of 12 weeks

Percentage of subjects that complete 12 sessions

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Adherence to Rehabilitation Protocol	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, maximum of 12 weeks

Mean number of missed and rescheduled rehabilitation sessions

Outcome measures

Measure	Vestibular Rehabilitation With Dynamic Posturography n=13 Participants 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Missed Sessions	0 number is missed sessions / participant Interval 0.0 to 0.0

Adverse Events

Vestibular Rehabilitation With Dynamic Posturography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eytan David

DR. EYTAN A. DAVID, MD, Otolaryngologist

Phone: (604) 988-0598

Email: dr.david@shaw.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place