Dizziness Chronic
Conditions
Keywords
Pilot study, Assessment of sway phase, Therapy trial phase
Brief summary
Researchers are gathering information on the safety and effectiveness of a new device called the BalanceBelt.
Detailed description
Ten consecutive subjects, ages 25-70 years, diagnosed with Chronic Subjective Dizziness (CDS) and ten healthy age and gender matched subjects will be asked to perform tests involving walking and balance while wearing the BalanceBelt. The BalanceBelt is a lightweight belt that will be worn under the clothes around the subjects waist and uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and motion.
Interventions
DEVICEBalance Belt
Vestibular habituation therapy worn under the clothes around the waist that uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and gait
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Subject population: 20 patients with diagnosis of Chronic Subjective Dizziness (CSD) and 10 normal volunteers. Inclusion Criteria: * Subjects will be 25-70 years of age inclusive and pregnant women may participate. * Patients will have CSD as their primary diagnosis for the cause of their balance and dizziness complaints provided by the Behavioral Medicine Program for Dizziness, a division of the Department of Psychiatry & Psychology. * Normal volunteers will have a negative history of otologic & neurologic disorders and no history of dizziness and balance problems. * Normal volunteers will have normal findings on a screening office examination for peripheral and central vestibular system involvement (see methods for details of the examination) and screening for normal or symmetrical hearing loss of explainable origin.
Exclusion criteria
* Patients with positive indications from testing of peripheral and/or central vestibular system involvement that is felt to be influencing the symptoms reported beyond the CSD alone. * Patients with mobility restriction that would prevent participating in the tests or the intensive therapy trials. * Subjects with hearing impairment that interferes with oral communication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degrees of Sway | baseline | The Sensory Organization Test is a six condition standard evaluation of balance control performed on a dynamic platform that can record sway movement in the A/P dimension while the sensory inputs from proprioception and vision are varied though the platform and visual surround movements. Condition 1 - eyes open, visual locked, platform locked. Condition 2 - eyes closed, visual locked, platform locked. Condition 3 - eyes open, visual unlocked, platform locked. Condition 4 - eyes open, visual locked, platform unlocked. Condition 5 - eyes closed, visual locked, platform unlocked. Condition 6 - eyes open, visual unlocked, platform unlocked. All participants progress though the exam, starting with condition 1 and ending with condition 6. All conditions were completed two to three times depending on performance with the average of each condition reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scales Score | baseline | For the therapy portion of the study aim #2 Visual Analog Scales (VAS) related to the intensity of symptoms provoked by visual motion, head movements and walking in visually complex environments. The average Visual Analog Scale scores for the patient group pre and post therapy will be compared for any significant difference in the score (p\<0.05). The VAS ranges from 0-10, where 0 is no symptoms and 10 is the most intense symptoms experienced. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic Subjective Dizziness Syndrome Subjects Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance. | 6 |
| Healthy Subjects Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Healthy Subjects | Total | Chronic Subjective Dizziness Syndrome Subjects |
|---|---|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 11.6 | 56.4 years STANDARD_DEVIATION 11.3 | 56.5 years STANDARD_DEVIATION 12.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Degrees of Sway
The Sensory Organization Test is a six condition standard evaluation of balance control performed on a dynamic platform that can record sway movement in the A/P dimension while the sensory inputs from proprioception and vision are varied though the platform and visual surround movements. Condition 1 - eyes open, visual locked, platform locked. Condition 2 - eyes closed, visual locked, platform locked. Condition 3 - eyes open, visual unlocked, platform locked. Condition 4 - eyes open, visual locked, platform unlocked. Condition 5 - eyes closed, visual locked, platform unlocked. Condition 6 - eyes open, visual unlocked, platform unlocked. All participants progress though the exam, starting with condition 1 and ending with condition 6. All conditions were completed two to three times depending on performance with the average of each condition reported.
Time frame: baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Subjective Dizziness Syndrome Subjects | Degrees of Sway | Condition 1 | 1.824 degrees of sway | Standard Error 0.266 |
| Chronic Subjective Dizziness Syndrome Subjects | Degrees of Sway | Condition 2 | 1.638 degrees of sway | Standard Error 0.259 |
| Chronic Subjective Dizziness Syndrome Subjects | Degrees of Sway | Condition 3 | 1.605 degrees of sway | Standard Error 0.252 |
| Chronic Subjective Dizziness Syndrome Subjects | Degrees of Sway | Condition 4 | 1.480 degrees of sway | Standard Error 0.259 |
| Chronic Subjective Dizziness Syndrome Subjects | Degrees of Sway | Condition 5 | 1.900 degrees of sway | Standard Error 0.27 |
| Chronic Subjective Dizziness Syndrome Subjects | Degrees of Sway | Condition 6 | 1.519 degrees of sway | Standard Error 0.274 |
| Healthy Subjects | Degrees of Sway | Condition 5 | 1.892 degrees of sway | Standard Error 0.278 |
| Healthy Subjects | Degrees of Sway | Condition 1 | 0.746 degrees of sway | Standard Error 0.278 |
| Healthy Subjects | Degrees of Sway | Condition 4 | 1.979 degrees of sway | Standard Error 0.259 |
| Healthy Subjects | Degrees of Sway | Condition 2 | 0.573 degrees of sway | Standard Error 0.287 |
| Healthy Subjects | Degrees of Sway | Condition 6 | 2.666 degrees of sway | Standard Error 0.274 |
| Healthy Subjects | Degrees of Sway | Condition 3 | 0.869 degrees of sway | Standard Error 0.278 |
Comparison: Condition 1 - eyes open, visual surround locked, platform lockedp-value: 0.005Kruskal-Wallis
Comparison: Condition 2 - eyes closed, visual surround locked, platform lockedp-value: 0.006Kruskal-Wallis
Comparison: Condition 3 - eyes open, visual surround unlocked, platform lockedp-value: 0.051Kruskal-Wallis
Comparison: Condition 4 - eyes open, visual surround locked, platform unlockedp-value: 0.173Kruskal-Wallis
Comparison: Condition 5 - eyes closed, visual surround locked, platform unlockedp-value: 0.985Kruskal-Wallis
Comparison: Condition 6 - eyes open, visual surround unlocked, platform unlockedp-value: 0.003Kruskal-Wallis
Secondary
Visual Analog Scales Score
For the therapy portion of the study aim #2 Visual Analog Scales (VAS) related to the intensity of symptoms provoked by visual motion, head movements and walking in visually complex environments. The average Visual Analog Scale scores for the patient group pre and post therapy will be compared for any significant difference in the score (p\<0.05). The VAS ranges from 0-10, where 0 is no symptoms and 10 is the most intense symptoms experienced.
Time frame: baseline
Population: This outcome measure was not evaluated in this study. No data have been collected for this outcome measure.