Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Washington University School of Medicine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Washington University School of Medicine
Collaborator:
Barron Associates, Inc.
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00889824
First received: April 27, 2009
Last updated: March 2, 2011
Last verified: March 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 27, 2009 | ||||||||
| Last Updated Date | March 2, 2011 | ||||||||
| Start Date ICMJE | February 2011 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Benefit of the balance device will be defined as clinically-and statistically-significant improvement in SOT-5 and SOT-6 scores, DGI scores, ABC Scale scores, and DHI scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00889824 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability | ||||||||
| Official Title ICMJE | Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Imbalance | ||||||||
| Intervention ICMJE | Device: balance prosthesis
vibrotatile stimulation |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 16 | ||||||||
| Estimated Completion Date | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00889824 | ||||||||
| Other Study ID Numbers ICMJE | 09-0600, 1R43DC010080-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Joel A. Goebel, M.D., Washington University School of Medicine | ||||||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||||||
| Collaborators ICMJE | Barron Associates, Inc. | ||||||||
| Investigators ICMJE |
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| Information Provided By | Washington University School of Medicine | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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