An interventional study of BALCAP prosthesis in Vestibular Disorder and Dizziness, sponsored by Barron Associates, Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-03-10.
Sponsored by Barron Associates, Inc. · Not applicable, Interventional, and Other
Among 54 studies in Vestibular Diseases with a site in United States — 14 open to participants now, 16 under way, none of them phase 3. Vestibular Diseases · United States.
Among the 54 studies in Vestibular Diseases with a site in United States, this one is the 36th largest by enrollment of the 48 interventional ones that give a count, is one of 2 that started in 2017, is one of 44 with no phase, and was the 14th registered.
170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
Browse Vestibular Diseases studies →14 of the 54 studies in Vestibular Diseases with a site in United States are open now. Recruiting first, the newest first:
Massachusetts Eye and Ear Infirmary · Sites in United States
Ages 21+ · Healthy volunteers
Creighton University · Sites in United States
Ages 19–89 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 22–90
Association of Migraine Disorders · Sites in United States
Ages 18+ · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 65–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Vestibular Diseases studies recruiting now, 6 (29%) set no upper age limit and 9 (43%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.
This study: 21 Years to 89 Years · all sexes · no healthy volunteers.
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54 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 13 is below the median of 46 across 127 interventional studies indexed under Vestibular Diseases.
Median enrollment 32 across the 48 interventional studies, 143 across the 6 observational. Of the 28 that completed or were terminated, 9 (32%) have results posted.
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10 of 54 have an industry lead sponsor. The 10 most frequent:
Barron Associates, Inc. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Barron Associates, Inc. has 1 study filed under Vestibular Diseases — fewer than ten, so there is no comparison to draw.
7 of the studies in Vestibular Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05674786Johns Hopkins UniversityVestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction | 2026-12-31 |
| NCT06732440Creighton UniversitySubthreshold Vestibular Stimulation as a Strategy for Rehabilitation | 2026-12-31 |
| NCT07081542AdventHealthComparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants | 2027-01-31 |
| NCT05622344Johns Hopkins UniversityStableEyes With Active Neurofeedback | 2027-03-30 |
| NCT06688578Massachusetts Eye and Ear InfirmaryTesting Effectiveness of a Stochastic Noise Stimulator to Immediately Improve Balance and Gait | 2027-05-31 |
Add all 7 to your calendar (.ics) → With an account.
Among the 54 studies in Vestibular Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this study is to evaluate a tactile prosthesis that provide individuals who have demonstrated chronic imbalance with help to maintain a correct sense of orientation with respect to the gravity and improve posture control.
The goal of this study is to evaluate a tactile prosthesis that provide individuals who have demonstrated chronic imbalance with help to maintain a correct sense of orientation with respect to the gravity and improve posture control. Chronic imbalance leads to significant problems. This study is designed to evaluate a device which can potentially improve the balance of these patients.
The participant will be asked to come to Washington University on three occasions for approximately 2 hours. Between visits, they will be asked to use the device daily (intervention condition) or to not use the device (control condition) for a prescribed period of time doing different activities. They will be provided written instructions from a physical therapist that will be determined by their individual ability. The activities will be typical exercises that are given to people with balance disorders. After 6 weeks of home use, participants will return for the second visit, and will repeat the evaluation. They will then return home and complete the either the control or intervention condition (which was not done the first time) in a crossover design.
On their first visit (week 0; baseline) participants will be asked to complete the same kind of tests that evaluated the function of their balance system at the time of their diagnosis. They will have their eye movements recorded using goggles and an infra-red camera while the prosthesis is in place and providing vibration feedback. Computerized Dynamic Posturography (CDP) testing will require them to stand on a platform and perform tests (20 seconds each) with their eyes open or closed, with the platform moving or still, and/or with the visual surround either stable or moving. They will be fitted with a safety harness that will keep them from falling. Next the investigators will evaluate their ability to perform movement tasks while walking (walking down the hall, walking down the hall avoiding objects, changing speeds while walking, going up and down stairs etc). They will walk a 25-foot distance at a comfortable gait speed, and again at a maximum gait speed. Lastly, they will be asked to fill out questionnaires.
On their second and last visit, they will repeat the evaluations that were performed during the first visit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants performed exercises daily at home wearing the BALCAP prosthesis for 6 weeks. After 6 weeks, participants performed the control condition (the same exercises without the BALCAP). Tests were performed before and after each 6-week period. Exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, with turns and movements other than straight forward walking, eyes open.
Device: BALCAP prosthesis
Participants performed exercises daily at home for 6 weeks without wearing the BALCAP prosthesis (control), followed by another 6 weeks of the same exercises with the BALCAP prosthesis (intervention). Tests were performed before and after each 6 week period. Exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, with turns and movements other than straight forward walking, eyes open.
Device: BALCAP prosthesis
The noninvasive BALCAP prosthesis offers uses six degrees-of-freedom (6-DOF) sensing to detect postural imbalance and actuate low-amplitude vibrotactile cues directly to the head to provide the wearer with feedback concerning head tilt in the pitch and roll plane.
Difference in Dynamic Gait Index (DGI)
This outcome compared the Dynamic Gait Index score when the BALCAP prosthesis was worn vs. when it was not worn at baseline in order to evaluate if there is an assistive benefit to wearing the device. The Dynamic Gait Index (DGI) is a clinical tool to assess gait, balance, and fall risk using various walking tasks. The range of scores is 0 to 24. A higher score is better. All participants performed this test at baseline both wearing the BALCAP and not wearing the BALCAP. This test does not measure a change in DGI score over time but compares the results of the test while wearing the BALCAP vs. not wearing the BALCAP during the same evaluation period (baseline).
Time frame: Week 0 (baseline)
Change in Computerized Dynamic Posturography: Equilibrium Score
Change in Computerized Dynamic Posturography (CDP): equilibrium score. Computerized Dynamic Posturography is used to assess balance disorders using a balance platform. CDP is used to determine postural stability; it measures a patient's ability to maintain balance under multiple conditions by testing visual, vestibular, and somatosensory balance components of the body. The equilibrium score is an overall indicator of balance. A score of 100 represents perfect stability and a score of 0 indicates a loss of balance. A higher value is better. This test is intended to ascertain if there is a rehabilitative benefit of using the BALCAP instrument.
Time frame: Before and after 6 weeks of either the intervention or the control condition
Difference in Gait Speed
The gait speed of each participant was measured over a 25-foot difference when wearing the BALCAP vs when not wearing the BALCAP. This test was performed on all participants at baseline prior to the home studies. A higher value represents faster gait speed. This test is intended to measure the assistive benefit of the BALCAP prosthesis.
Time frame: Week 0 (baseline)
Change in Activities-specific Balance Confidence (ABC) Scale
Change in Activities-specific Balance Confidence (ABC) Scale. The Activities-specific Balance Confidence Scale is a self-report questionnaire that measures an individual's confidence in performing activities without losing balance. The score range is from 0 to 100. A higher value is better.
Time frame: Before and after 6 weeks of either the intervention or the control condition
Change in Dizziness Handicap Inventory Score
Change in Dizziness Handicap Inventory score. The Dizziness Handicap Inventory (DHI) is a common self-report quality of life measure for vestibular disorders. The score range is from 0 to 100 and a lower score is better. This test is intended to ascertain if there is a rehabilitative benefit of using the BALCAP instrument.
Time frame: Before and after 6 weeks of either the intervention or the control condition
| Milestone | BALCAP Prosthesis, Then Control | Control, Then BALCAP Prosthesis |
|---|---|---|
| Started | 7 | 6 |
| Completed | 7 | 6 |
| Not completed | 0 | 0 |
| Milestone | BALCAP Prosthesis, Then Control | Control, Then BALCAP Prosthesis |
|---|---|---|
| Started | 7 | 6 |
| Completed | 5 | 5 |
| Not completed | 2 | 1 |
This outcome compared the Dynamic Gait Index score when the BALCAP prosthesis was worn vs. when it was not worn at baseline in order to evaluate if there is an assistive benefit to wearing the device. The Dynamic Gait Index (DGI) is a clinical tool to assess gait, balance, and fall risk using various walking tasks. The range of scores is 0 to 24. A higher score is better. All participants performed this test at baseline both wearing the BALCAP and not wearing the BALCAP. This test does not measure a change in DGI score over time but compares the results of the test while wearing the BALCAP vs. not wearing the BALCAP during the same evaluation period (baseline).
| units on a scale | All Participants |
|---|---|
| Difference in Dynamic Gait Index (DGI) | 0.77 (0.16 to 1.38) |
Change in Computerized Dynamic Posturography (CDP): equilibrium score. Computerized Dynamic Posturography is used to assess balance disorders using a balance platform. CDP is used to determine postural stability; it measures a patient's ability to maintain balance under multiple conditions by testing visual, vestibular, and somatosensory balance components of the body. The equilibrium score is an overall indicator of balance. A score of 100 represents perfect stability and a score of 0 indicates a loss of balance. A higher value is better. This test is intended to ascertain if there is a rehabilitative benefit of using the BALCAP instrument.
| units on a scale | BALCAP Prosthesis | Control |
|---|---|---|
| Change in Computerized Dynamic Posturography: Equilibrium Score | 5.94 (1.8 to 10.9) | 0.34 (-3.81 to 4.49) |
The gait speed of each participant was measured over a 25-foot difference when wearing the BALCAP vs when not wearing the BALCAP. This test was performed on all participants at baseline prior to the home studies. A higher value represents faster gait speed. This test is intended to measure the assistive benefit of the BALCAP prosthesis.
| meters/second | All Participants |
|---|---|
| Difference in Gait Speed | 0.03 (-0.05 to 0.11) |
Change in Activities-specific Balance Confidence (ABC) Scale. The Activities-specific Balance Confidence Scale is a self-report questionnaire that measures an individual's confidence in performing activities without losing balance. The score range is from 0 to 100. A higher value is better.
| units on a scale | BALCAP Prosthesis | Control |
|---|---|---|
| Change in Activities-specific Balance Confidence (ABC) Scale | 6.04 (-5.45 to 17.53) | 1.39 (-10.10 to 12.88) |
Change in Dizziness Handicap Inventory score. The Dizziness Handicap Inventory (DHI) is a common self-report quality of life measure for vestibular disorders. The score range is from 0 to 100 and a lower score is better. This test is intended to ascertain if there is a rehabilitative benefit of using the BALCAP instrument.
| units on a scale | BALCAP Prosthesis | Control |
|---|---|---|
| Change in Dizziness Handicap Inventory Score | -7.33 (-18.66 to 3.99) | 2.00 (-9.32 to 13.32) |
Collected over The 12 weeks of each participant's study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BALCAP Prosthesis | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Control | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Categorical(Participants) | BALCAP Prosthesis, Then Control | Control, Then BALCAP Prosthesis | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 4 |
| >=65 years | 5 | 4 | 9 |
| Age, Continuous(years) | BALCAP Prosthesis, Then Control | Control, Then BALCAP Prosthesis | Total |
|---|---|---|---|
| Mean | 68 ± 10.7 | 71.6 ± 11.5 | 69.7 ± 10.8 |
| Sex: Female, Male(Participants) | BALCAP Prosthesis, Then Control | Control, Then BALCAP Prosthesis | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 4 | 3 | 7 |
| Race (NIH/OMB)(Participants) | BALCAP Prosthesis, Then Control | Control, Then BALCAP Prosthesis | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 7 | 6 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | BALCAP Prosthesis, Then Control | Control, Then BALCAP Prosthesis | Total |
|---|---|---|---|
| United States | 7 | 6 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Nov 2018, 13 months.
Results were first posted in Mar 2021, 2 years 3 months after primary completion.
Of 84 interventional studies with no phase under Vestibular Diseases, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Barron Associates, Inc.