Dizziness
Conditions
Keywords
rehabilitation, aged, aged, 80 and over, vestibular diseases
Brief summary
The purpose of this study is to determine whether vestibular exercises provide added benefit to balance rehabilitation in older adults with dizziness and normal vestibular function.
Detailed description
Dizziness is among the most prevalent complaints for which people seek medical help and the incidence increases with advancing age. Dizziness represents a diagnostic and treatment challenge because it is a subjective sensation, refers to a variety of symptoms (unsteadiness, spinning, sense of motion or lightheadedness), and has many potential contributory factors. Dizziness is often related to vestibular disease which is treated effectively with vestibular exercises. Successful management of dizziness is critical because dizziness is a major risk factor for falls in older adults. There are parallels between the effects of age-related versus disease-related loss of vestibular function - in complaints of dizziness and increased risk for falls. The investigators' question, then, is whether the same exercises that are beneficial for patients with vestibular pathology are beneficial for older patients with dizziness but normal vestibular function. Older adults with dizziness who have been referred to Audiology for vestibular evaluation will be randomized to receive either standard balance rehabilitation plus placebo eye exercises (CON) or standard balance rehabilitation plus vestibular-specific exercises (GS). Primary outcomes include symptoms, balance-related confidence, dynamic visual acuity, postural stability as measured by sensory organization test, fall risk as measured by dynamic gait index, and gait speed. Assessment will occur at baseline, discharge from physical therapy (PT), 1 and 6 months post-PT.
Interventions
BEHAVIORALstandard 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 with progressively challenging tasks. Balance exercises include maintaining stability with vision and somatosensory cues altered, dynamic weight shifts and performing ankle, hip and step strategies. Gait activities include negotiating uneven terrains and obstacles, gait with head turns, varied speed, and unpredictable starts and stops. 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.
BEHAVIORALgaze stability
Vestibular adaptation and substitution exercises will be performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target, which may be stationary or moving. Typical progression of adaptation exercises involve increased velocity of head movement, movement of both target and head, 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, potentially facilitating use of preprogrammed eye movements.
BEHAVIORALControl
The placebo exercises will consist of saccadic eye movements while the head is stationary and will be performed by the control group. These eye movements will be performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 50 years of age * documented balance or mobility problems * normal vestibular function, including otolith function
Exclusion criteria
* cognitive impairment * progressive medical issues that would impact mobility (e.g., Parkinson's disease, cerebellar atrophy) * dizziness due to orthostatic hypotension or Benign Paroxysmal Positional Vertigo (BPPV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale - Head Movement | 6 weeks | 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. |
| Visual Analog Scale - Disequilibrium | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index | 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. |
| 10 Meter Walk Test | 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. |
| Activities-specific Balance Confidence Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gaze Stability (GS) 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. | 13 |
| Control (CON) 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. | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | disqualified | 2 | 5 |
| Overall Study | Withdrawal by Subject | 8 | 7 |
Baseline characteristics
| Characteristic | Total | Control (CON) | Gaze Stability (GS) |
|---|---|---|---|
| 10 Meter Walk Test | 3.00 ft/s STANDARD_DEVIATION 0.57 | 2.96 ft/s STANDARD_DEVIATION 0.58 | 3.05 ft/s STANDARD_DEVIATION 0.58 |
| Activities-specific balance confidence scale | 74.00 percentage STANDARD_DEVIATION 16.42 | 78.03 percentage STANDARD_DEVIATION 9.68 | 69.64 percentage STANDARD_DEVIATION 21.12 |
| Age, Continuous | 71.15 years STANDARD_DEVIATION 7.47 | 72.36 years STANDARD_DEVIATION 6.07 | 69.85 years STANDARD_DEVIATION 8.8 |
| Dynamic Gait Index | 18.41 units on a scale STANDARD_DEVIATION 2.83 | 18.36 units on a scale STANDARD_DEVIATION 2.62 | 18.46 units on a scale STANDARD_DEVIATION 3.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 14 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 12 Participants | 13 Participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Male | 18 Participants | 9 Participants | 9 Participants |
| Visual Analog Scale - Disequilibrium | 2.29 units on a scale STANDARD_DEVIATION 1.95 | 2.74 units on a scale STANDARD_DEVIATION 2.1 | 1.77 units on a scale STANDARD_DEVIATION 1.69 |
| Visual Analog Scale - Head Movement | 2.33 units on a scale STANDARD_DEVIATION 2.68 | 2.58 units on a scale STANDARD_DEVIATION 2.74 | 2.06 units on a scale STANDARD_DEVIATION 2.69 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 23 | 0 / 26 |
| other Total, other adverse events | 0 / 23 | 1 / 26 |
| serious Total, serious adverse events | 1 / 23 | 0 / 26 |
Outcome results
Primary
Visual Analog Scale - Disequilibrium
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.
Time frame: 6 weeks
Population: Repeated Measure (RM) ANOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gaze Stability | Visual Analog Scale - Disequilibrium | 1.66 units on a scale | Standard Deviation 2.29 |
| Control | Visual Analog Scale - Disequilibrium | 1.96 units on a scale | Standard Deviation 2.37 |
p-value: 0.17ANOVA
p-value: 0.297ANOVA
Primary
Visual Analog Scale - Head Movement
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gaze Stability | Visual Analog Scale - Head Movement | 1.56 units on a scale | Standard Deviation 2.55 |
| Control | Visual Analog Scale - Head Movement | 1.81 units on a scale | Standard Deviation 2.08 |
p-value: 0.356ANOVA
p-value: 0.84ANOVA
Secondary
10 Meter Walk Test
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gaze Stability | 10 Meter Walk Test | 3.15 ft/s | Standard Deviation 0.54 |
| Control | 10 Meter Walk Test | 3.28 ft/s | Standard Deviation 0.69 |
p-value: 0.009ANOVA
p-value: 0.146ANOVA
Secondary
Activities-specific Balance Confidence Scale
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gaze Stability | Activities-specific Balance Confidence Scale | 83.98 percentage | Standard Deviation 14.4 |
| Control | Activities-specific Balance Confidence Scale | 83.37 percentage | Standard Deviation 6.3 |
p-value: 0.005ANOVA
p-value: 0.172ANOVA
Secondary
Dynamic Gait Index
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gaze Stability | Dynamic Gait Index | 21.54 units on a scale | Standard Deviation 2.02 |
| Control | Dynamic Gait Index | 21.21 units on a scale | Standard Deviation 2.78 |
p-value: <0.001ANOVA
p-value: 0.817ANOVA