Trial Outcomes & Findings for Vestibular Rehabilitation and Dizziness (NCT NCT01729039)

Last Updated: 2018-08-22

Results Overview

This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Gaze Stability Standard balance rehabilitation plus Vestibular-specific exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Vestibular-specific exercises: Gaze stability exercises are performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target. Progression involves increased velocity of head movement and target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.	Control Standard balance rehabilitation plus Placebo eye exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Control: Placebo exercises consist of saccadic eye movements while the head is stationary and are performed by the control group (CON). These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
Overall Study STARTED	23	26
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Gaze Stability Standard balance rehabilitation plus Vestibular-specific exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Vestibular-specific exercises: Gaze stability exercises are performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target. Progression involves increased velocity of head movement and target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.	Control Standard balance rehabilitation plus Placebo eye exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Control: Placebo exercises consist of saccadic eye movements while the head is stationary and are performed by the control group (CON). These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
Overall Study disqualified	2	5
Overall Study Withdrawal by Subject	8	7

Baseline Characteristics

Vestibular Rehabilitation and Dizziness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gaze Stability (GS) n=13 Participants Gaze Stability group intervention includes standard balance rehabilitation plus vestibular-specific exercises. Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Vestibular-specific exercises: Gaze stability exercises involve head movement while maintaining focus on a target. Progression involves increased velocity of head movement and target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.	Control (CON) n=14 Participants Control group intervention includes standard balance rehabilitation plus placebo eye exercises. Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Control exercises: Placebo eye exercises consist of saccadic eye movements while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.	Total n=27 Participants Total of all reporting groups
Age, Continuous	69.85 years STANDARD_DEVIATION 8.80 • n=5 Participants	72.36 years STANDARD_DEVIATION 6.07 • n=7 Participants	71.15 years STANDARD_DEVIATION 7.47 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Visual Analog Scale - Head Movement	2.06 units on a scale STANDARD_DEVIATION 2.69 • n=5 Participants	2.58 units on a scale STANDARD_DEVIATION 2.74 • n=7 Participants	2.33 units on a scale STANDARD_DEVIATION 2.68 • n=5 Participants
Visual Analog Scale - Disequilibrium	1.77 units on a scale STANDARD_DEVIATION 1.69 • n=5 Participants	2.74 units on a scale STANDARD_DEVIATION 2.10 • n=7 Participants	2.29 units on a scale STANDARD_DEVIATION 1.95 • n=5 Participants
Dynamic Gait Index	18.46 units on a scale STANDARD_DEVIATION 3.15 • n=5 Participants	18.36 units on a scale STANDARD_DEVIATION 2.62 • n=7 Participants	18.41 units on a scale STANDARD_DEVIATION 2.83 • n=5 Participants
Activities-specific balance confidence scale	69.64 percentage STANDARD_DEVIATION 21.12 • n=5 Participants	78.03 percentage STANDARD_DEVIATION 9.68 • n=7 Participants	74.00 percentage STANDARD_DEVIATION 16.42 • n=5 Participants
10 Meter Walk Test	3.05 ft/s STANDARD_DEVIATION 0.58 • n=5 Participants	2.96 ft/s STANDARD_DEVIATION 0.58 • n=7 Participants	3.00 ft/s STANDARD_DEVIATION 0.57 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Gaze Stability n=13 Participants Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.	Control n=14 Participants Control group (CON) intervention includes standard balance rehabilitation plus placebo eye exercises. Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
Visual Analog Scale - Head Movement	1.56 units on a scale Standard Deviation 2.55	1.81 units on a scale Standard Deviation 2.08

PRIMARY outcome

Timeframe: 6 weeks

Population: Repeated Measure (RM) ANOVA

This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.

Outcome measures

Outcome measures
Measure	Gaze Stability n=13 Participants Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.	Control n=14 Participants Control group (CON) intervention includes standard balance rehabilitation plus placebo eye exercises. Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
Visual Analog Scale - Disequilibrium	1.66 units on a scale Standard Deviation 2.29	1.96 units on a scale Standard Deviation 2.37

SECONDARY outcome

Timeframe: 6 weeks

The dynamic gait index (DGI) assesses an individual's ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of \< 20 indicate high risk for falling.

Outcome measures

Outcome measures
Measure	Gaze Stability n=13 Participants Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.	Control n=14 Participants Control group (CON) intervention includes standard balance rehabilitation plus placebo eye exercises. Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
Dynamic Gait Index	21.54 units on a scale Standard Deviation 2.02	21.21 units on a scale Standard Deviation 2.78

SECONDARY outcome

Timeframe: 6 weeks

As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure the subject's confidence with their balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.

Outcome measures

Outcome measures
Measure	Gaze Stability n=13 Participants Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.	Control n=14 Participants Control group (CON) intervention includes standard balance rehabilitation plus placebo eye exercises. Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
Activities-specific Balance Confidence Scale	83.98 percentage Standard Deviation 14.40	83.37 percentage Standard Deviation 6.30

SECONDARY outcome

Timeframe: 6 weeks

This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.

Outcome measures

Outcome measures
Measure	Gaze Stability n=13 Participants Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.	Control n=14 Participants Control group (CON) intervention includes standard balance rehabilitation plus placebo eye exercises. Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
10 Meter Walk Test	3.15 ft/s Standard Deviation 0.54	3.28 ft/s Standard Deviation 0.69

Adverse Events

Gaze Stability

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gaze Stability n=23 participants at risk Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.	Control n=26 participants at risk Control group (CON intervention includes standard balance rehabilitation plus placebo eye exercises. Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
Musculoskeletal and connective tissue disorders Fall resulting in fracture	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/26 • 6 months

Other adverse events

Other adverse events
Measure	Gaze Stability n=23 participants at risk Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.	Control n=26 participants at risk Control group (CON intervention includes standard balance rehabilitation plus placebo eye exercises. Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home. Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
Musculoskeletal and connective tissue disorders Fall without injury	0.00% 0/23 • 6 months	3.8% 1/26 • Number of events 1 • 6 months

Additional Information

Dr. Courtney Hall

James H Quillen VAMC

Phone: 423-926-1171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place