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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43DC010080-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Barron Associates, Inc. | INDUSTRY |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The goal of this project is to provide individuals that have a balance deficit with a device that will give them signals that they can feel (vibrations) in order to help them maintain a correct sense of balance and perception of place in the environment.
This proposal addresses a National Institute on Deafness and Other communication Disorders (NIDCD) research topic that emphasizes the "development of assistive devices for balance disorders". The proposed work will evaluate the assistive efficacy of such a balance prosthesis in a population of chronic imbalance patients spanning a wide range of disease etiologies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prosthesis group | Experimental | balance prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balance prosthesis | Device | vibrotactile stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks. | The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel A Goebel, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
There was no run-in or washout. All participants received the intervention.
Participants were recruited from 7/10/2009 through 6/30/2012 from Dr. Goebel's clinical practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Balcap Group | Balcap group Balcap group; balance prosthesis : vibrotactile stimulation Patients wore a Balcap device that provided a vibrotactile stimulation that felt like a "buzz" either in front, back, or either side of their head when they swayed a certain distance from their "center". They wore the device daily and performed specific personalized exercises as prescribed by a physical therapist. They were tested with and without the balcap during tests of balance and postural stability when they first received the balcap and again six weeks later. Each patient wore the balcap device a total of six weeks and then returned the device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Balcap Group | Each participant received Balcap Tactile prosthesis |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks. | The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24. | The Dynamic Gait Index (DGI) data were analyzed by way of an linear mixed (LM) model. The DGI response data were treated as the dependent observations. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
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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 | Balcap Group | Each participant received Balcap Tactile prosthesis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel Goebel, MD | WashingtonU | (314) 362-7344 | goebelj@ent.wustl.edu |
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| ID | Term |
|---|---|
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 5 |
| 0 |
| 5 |
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