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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gaze stability | Experimental | standard balance rehabilitation plus vestibular-specific exercises |
|
| control | Placebo Comparator | standard balance rehabilitation plus placebo eye exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard balance rehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney D Hall, PhD PT | Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033 | United States | ||
| Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gaze Stability | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall resulting in fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Fall while performing home exercise program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall without injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Loss of balance without injury while performing home exercise program |
High dropout rate; small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Courtney Hall | James H Quillen VAMC | 423-926-1171 | 7518 | courtney.hall@va.gov |
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| ID | Term |
|---|---|
| D004244 | Dizziness |
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| gaze stability | Behavioral | 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. |
|
| Control | Behavioral | 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. |
|
| 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| Mountain Home |
| Tennessee |
| 37684 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Visual Analog Scale - Head Movement | This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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 confidence with 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. | Mean | Standard Deviation | percentage |
|
| 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. | Mean | Standard Deviation | ft/s |
|
| OG001 | Control | 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. |
|
|
|
| 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. | Repeated Measure (RM) ANOVA | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage | 6 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | ft/s | 6 weeks |
|
|
|
|
| 1 |
| 23 |
| 1 |
| 23 |
| 0 |
| 23 |
| EG001 | Control | 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. | 0 | 26 | 0 | 26 | 1 | 26 |
|
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| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Interaction of Time by Group (GS vs. CON) alpha = .05 |
| Superiority |
Interaction of Time by Group (GS vs. CON) alpha = .05 |
| Superiority |
Interaction of Time by Group (GS vs. CON) alpha = .05 |
| Superiority |
Interaction of Time by Grou (GS vs. CON) alpha = .05 |
| Superiority |