Ear Diseases, Labyrinth Diseases, Otorhinolaryngologic Diseases, Traumatic Brain Injury, Vestibular Diseases
Conditions
Keywords
Keywords provided by BalanceSense, LLC:, Physical Therapy, Rehabilitation, Disequilibrium, Balance dysfunction or disorder, Vestibular, Mild Traumatic Brain Injury (mTBI), Vibrotactile
Brief summary
Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance physical therapy for rehabilitation of patients who fall as a result of vestibular inducted disequilibrium. Study participants will receive regular physical therapy, and some will use the SEMD device while receiving usual care vestibular-balance physical therapy. The device is an elastic belt that holds eight small battery powered vibrating disks. When using the device, you will sit or stand on a force platform that measures body sway. That movement information is sent to a computer which then sends the information to you via the vibrating disks. The vibrating disks are similar to a vibrating cell phone: you can feel the vibration but it is not uncomfortable. You can also see your sway movement on the computer screen. Some tests and activities will be paced with a beeping sound. The aim of this study is six-fold: 1. Demonstrate the relative efficiency between SEMD and conventional vestibular-balance physical therapy as reported by treating physical therapists' by counting number of skills acquired in a treatment session, and the amount of time needed to acquire the skill; 2. Demonstrate greater improvement earlier on in balance test scores when using the SEMD as an adjunct to conventional vestibular-balance physical therapy; 3. Determine the difference in vestibular habituation between physical therapy plus SEMD and conventional vestibular-balance physical therapy; 4. Demonstrate a more immediate reduction in fall occurrence when using SEMD as an adjunct to conventional vestibular-balance physical therapy; 5. Determine the patient's perception of quality of life between physical therapy plus SEMD and conventional vestibular-balance physical therapy; 6. Determine difference in acquisition of large movement tasks of tandem walk, step quick-turn, and kneel-shoulder rifle-return to stand between subjects that have trained with SEMD and conventional vestibular-balance physical therapy . In addition to primary and secondary outcome measurements, efficiency of skill acquisition, devised for this study, will be evaluated by tracking the number of skills and length of time needed to acquire each skill for each physical therapy session using the Patient Skill Acquisition Chart (PSAC). Usefulness of Tandem Walk, Step Quick-turn, and Kneel- Shoulder Rifle-Return to Stand as intervention outcome, also devised for this study, will be evaluated with pre test to post tests Modified Functional Independence Measure - Motor (MFIM-Motor). These measurements were devised for this study, and will be evaluated for informational purposes only.
Detailed description
This study will compare two approaches of physical therapy intervention within vestibular deficit populations that frequently fall: 1. physical therapy plus SEMD, and 2. usual care physical therapy only. Multimodal sensory cueing gives additional or enriched information to complement postural and mobility decisions. SEMD displays combine vibrotactile, visual and audio cueing that are intuitive and non-intrusive within a balance training system. Study intervention includes a maximum of 12 physical therapy intervention sessions, 2 times per week for 6 weeks or normalization of SOT, whichever occurs first. Usual care physical therapy prescriptions are written specific for number of sessions over a specific duration of time. Discharge from physical therapy occurs when number of sessions within a specified period of time is exhausted or goals specified by the physical therapist are met. Data collection includes 1 pre test and 4 post tests at intervals during the weeks of intervention, plus 3 follow-up phone interviews at specified intervals after intervention for maximal study duration of 6 months. A patient must attend at least 4 physical therapy intervention sessions for their data to be used and for the follow-up phone interviews to be initiated.
Interventions
DEVICEUsual care physical therapy plus SEMD
Patients will receive usual care physical therapy while wearing SEMD. SEMD protocols will also be provided to device subjects.
OTHERUsual care physical therapy only
Subjects will receive usual care physical therapy from vestibular and balance specialists.
Sponsors
Karen L Atkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
1. Self-reporting 2 or more falls with or without injury within the past 6 months. 2. Below normal SOT containing a abnormal vestibular score. 3. Potential to benefit from physical therapy as indicated by physician prescription referral. 4. Able to sit and to stand unaided for 2 minutes. 5. Willing and able to complete all testing, training, and follow-up evaluations required by the study protocol.
Exclusion criteria
1. Fluctuating Meniere's 2. Vestibular injury requiring surgery such as perilymph fistula 3. Moderate progressive neurologic disease such as multiple sclerosis 4. Does not speak and understand the English language 5. Resides in a nursing home 6. Unable to provide own consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT). | Pre Test to Post Test 1 after two physical therapy sessions (one week) | Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway. |
| Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT). | Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks) | Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway. |
| Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT). | Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks) | Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway. |
| Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT). | Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks) | Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2 | Pre Test to Post Test 2 after four physical therapy sessions within 10 days | Functional Gait Assessment is a 10-item gait assessment based on the Dynamic Gait Index. Requirements: A marked 20 foot walkway that is marked with a 12 inch width. Scoring: a four-point ordinal scale, ranging from 0-3 where 0 indicates the lowest level of function and 3 the highest level of function. Total Score = 30 with higher score indicating safer ambulation with lower risk of falling. Criterion Validity: Authors support a cut off score of 23/30 for independent safe ambulation. Interpretation: 1) 0-19 is predictive of falls in the elderly. 2) 20-22 indicates likelihood of unexplained fall in community-dwelling, older adults, and predictive of likelihood of falling in patients with vestibular disorders. 3\) 23-30 = safe ambulators |
| Head Shake Sensory Organization Test (HS_SOT) | Pre Test, Post Test 1 and Post Test 4 | Head Shake Sensory Organization Test (HS-SOT) HS-SOT instructs the patient to static stand shoulder width apart with eyes closed and uses the SOT Condition 5 sway surface protocol while shaking the head horizontally 120 degrees per second. This protocol is safe for patients when they have normalized all SOT scores. Because study subjects were reaching SOT normalization after Post Test 2, the data collected was scant and not suitable for analysis. |
| Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1 | Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days | A fall is an unintentional change in position causing an individual to land at a lower level, on an object, the floor, the ground or other surface with or without injury. This includes: slips, trips, falling into other people, being lowered, loss of balance, and legs giving way. (Exclude sudden onset of paralysis, epileptic seizure, or overwhelming external force.) |
| Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2 | Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days. | Berg Balance Scale Description: 14-item scale designed to measure balance of the older adult in a clinical setting, and measures mobility related to activities of daily living. Description: This 14-item performance-based instrument is intended for individuals with some degree of balance impairment. Scoring: A five-point ordinal scale, ranging from 0-4. 0 indicates the lowest level of function and 4 the highest level of function. Total Score = 56 with higher score indicting safer ambulation with lower risk of falling. Criterion Validity: Authors support a cut off score of 45/56 for independent safe ambulation. Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk Riddle and Stratford, 1999, examined 45/56 cutoff validity and concluded: * Sensitivity = 64% (Correctly predicts fallers) * Specificity = 90% (Correctly predicts non-fallers) |
| Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4 | Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days | Vestibular Rehabilitation Benefit Questionnaire asks the patient to self-rate disability as it affects their quality of life. Scale goes from zero, no disability, to 100 or maximal disability. The Total Benefit includes two subsets: 1) dizziness symptoms, and 2) quality of life. |
Countries
United States
Participant flow
Recruitment details
Recruitment continued for one year resulting in 39 subjects pre screened for inclusion in the study.
Pre-assignment details
Seven subjects who had signed Informed Consent prior to inclusion/exclusion screening failed screening: thirty-two subjects participated in the physical therapy protocol.
Participants by arm
| Arm | Count |
|---|---|
| Conventional Care Physical Therapy Only Subjects received usual physical therapy intervention provided by vestibular and balance specialists. | 11 |
| Conventional Physical Therapy Plus SEMD Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy. | 14 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Conventional Physical Therapy Plus SEMD | Conventional Care Physical Therapy Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 8 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Continuous | 73.35 years STANDARD_DEVIATION 7.46 | 69.44 years STANDARD_DEVIATION 10 | 71.64 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment United States | 14 participants | 11 participants | 25 participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 |
Outcome results
Primary
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT).
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Time frame: Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Care Physical Therapy Only | Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT). | 5.09 units on a scale | Standard Deviation 6.7 |
| Conventional Physical Therapy Plus SEMD | Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT). | .86 units on a scale | Standard Deviation 6.57 |
Primary
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT).
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Time frame: Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Care Physical Therapy Only | Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT). | 9.36 units on a scale | Standard Deviation 12.8 |
| Conventional Physical Therapy Plus SEMD | Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT). | 5.00 units on a scale | Standard Deviation 8.49 |
Primary
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT).
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Time frame: Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Care Physical Therapy Only | Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT). | 3.27 units on a scale | Standard Deviation 7.94 |
| Conventional Physical Therapy Plus SEMD | Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT). | 8.86 units on a scale | Standard Deviation 7.72 |
Primary
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT).
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Time frame: Pre Test to Post Test 1 after two physical therapy sessions (one week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Care Physical Therapy Only | Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT). | 9.82 units on a scale | Standard Deviation 10.68 |
| Conventional Physical Therapy Plus SEMD | Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT). | 7.29 units on a scale | Standard Deviation 9.33 |
p-value: 0.533ANOVA
Secondary
Head Shake Sensory Organization Test (HS_SOT)
Head Shake Sensory Organization Test (HS-SOT) HS-SOT instructs the patient to static stand shoulder width apart with eyes closed and uses the SOT Condition 5 sway surface protocol while shaking the head horizontally 120 degrees per second. This protocol is safe for patients when they have normalized all SOT scores. Because study subjects were reaching SOT normalization after Post Test 2, the data collected was scant and not suitable for analysis.
Time frame: Pre Test, Post Test 1 and Post Test 4
Secondary
Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2
Berg Balance Scale Description: 14-item scale designed to measure balance of the older adult in a clinical setting, and measures mobility related to activities of daily living. Description: This 14-item performance-based instrument is intended for individuals with some degree of balance impairment. Scoring: A five-point ordinal scale, ranging from 0-4. 0 indicates the lowest level of function and 4 the highest level of function. Total Score = 56 with higher score indicting safer ambulation with lower risk of falling. Criterion Validity: Authors support a cut off score of 45/56 for independent safe ambulation. Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk Riddle and Stratford, 1999, examined 45/56 cutoff validity and concluded: * Sensitivity = 64% (Correctly predicts fallers) * Specificity = 90% (Correctly predicts non-fallers)
Time frame: Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Care Physical Therapy Only | Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2 | 43 percentage of participants |
| Conventional Physical Therapy Plus SEMD | Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2 | 100 percentage of participants |
Secondary
Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2
Functional Gait Assessment is a 10-item gait assessment based on the Dynamic Gait Index. Requirements: A marked 20 foot walkway that is marked with a 12 inch width. Scoring: a four-point ordinal scale, ranging from 0-3 where 0 indicates the lowest level of function and 3 the highest level of function. Total Score = 30 with higher score indicating safer ambulation with lower risk of falling. Criterion Validity: Authors support a cut off score of 23/30 for independent safe ambulation. Interpretation: 1) 0-19 is predictive of falls in the elderly. 2) 20-22 indicates likelihood of unexplained fall in community-dwelling, older adults, and predictive of likelihood of falling in patients with vestibular disorders. 3\) 23-30 = safe ambulators
Time frame: Pre Test to Post Test 2 after four physical therapy sessions within 10 days
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Conventional Care Physical Therapy Only | Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2 | 20 percentage of participants | 2.38 |
| Conventional Physical Therapy Plus SEMD | Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2 | 77 percentage of participants | 2.01 |
Secondary
Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1
A fall is an unintentional change in position causing an individual to land at a lower level, on an object, the floor, the ground or other surface with or without injury. This includes: slips, trips, falling into other people, being lowered, loss of balance, and legs giving way. (Exclude sudden onset of paralysis, epileptic seizure, or overwhelming external force.)
Time frame: Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Care Physical Therapy Only | Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1 | 9 percentage of participants |
| Conventional Physical Therapy Plus SEMD | Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1 | 54 percentage of participants |
Secondary
Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4
Vestibular Rehabilitation Benefit Questionnaire asks the patient to self-rate disability as it affects their quality of life. Scale goes from zero, no disability, to 100 or maximal disability. The Total Benefit includes two subsets: 1) dizziness symptoms, and 2) quality of life.
Time frame: Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Care Physical Therapy Only | Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4 | Pre Test | 39.14 units on a scale | Standard Deviation 17.95 |
| Conventional Care Physical Therapy Only | Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4 | Post Test 4 | 31.27 units on a scale | Standard Deviation 8.25 |
| Conventional Physical Therapy Plus SEMD | Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4 | Pre Test | 34.30 units on a scale | Standard Deviation 6.52 |
| Conventional Physical Therapy Plus SEMD | Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4 | Post Test 4 | 28.32 units on a scale | Standard Deviation 11.1 |