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Use of a Vibrotactile Sensory Prosthesis in Patients With Postural Imbalance and Spatial Disorientation

Primary Purpose

Vestibular Diseases, Peripheral Neuropathies, Proprioceptive Disorders

Status

Unknown status

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Vibrotactile feedback

About this trial

This is an interventional diagnostic trial for Vestibular Diseases focused on measuring Hemineglects

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Sensory impairments Unsteadiness Exclusion Criteria: High strokes

Sites / Locations

Charing Cross HospitalRecruiting

Outcomes

Primary Outcome Measures

Mean time reaction to the perturbation with the feedback

Secondary Outcome Measures

Full Information

NCT ID

NCT00146952

First Posted

September 5, 2005

Last Updated

November 10, 2016

Sponsor

Imperial College London

Collaborators

Medical Research Council

1. Study Identification

Unique Protocol Identification Number

NCT00146952

Brief Title

Use of a Vibrotactile Sensory Prosthesis in Patients With Postural Imbalance and Spatial Disorientation

Official Title

Evaluation of a Vibrotactile Sensory Aid Developed by the US Navy to Combat Pilot Disorientation as a Prosthesis in Patients With Postural Imbalance and Spatial Disorientation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

January 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Imperial College London

Collaborators

Medical Research Council

4. Oversight

5. Study Description

Brief Summary

The investigators propose to explore the hypothesis that vibrotactile channels for indicating spatial orientation can be exploited as a sensory prosthesis. The specific research applications will be used for guiding visual orientation, to provide alternative feedback to vision and vestibular signals for controlling balance, and for directional and lateralisation cueing in patients with neglect syndromes. The programme will study whether vibrotactile feedback improves performance and also if it speeds rehabilitation when used as an adjunct to conventional therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vestibular Diseases, Peripheral Neuropathies, Proprioceptive Disorders, Hemispatial Neglect

Keywords

Hemineglects

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Vibrotactile feedback

Primary Outcome Measure Information:

Title

Mean time reaction to the perturbation with the feedback

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sensory impairments Unsteadiness Exclusion Criteria: High strokes

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael A Gresty, Pr

Phone

020-8846

Ext

7634

m.gresty@imperial.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Francois B Asseman, Dr

Phone

020-8383

Ext

5525

f.asseman@imperial.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael A Gresty, Pr

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adolfo M Bronstein, Pr, MD

Organizational Affiliation

Imperial College London

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Christopher Kennard, Pr, MD

Organizational Affiliation

Imperial College London

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Masud Husain, Dr

Organizational Affiliation

Imperial College London

Official's Role

Study Director

Facility Information:

Facility Name

Charing Cross Hospital

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael A Gresty, Pr

Phone

020-8846

Ext

7634

m.gresty@imperial.ac.uk

First Name & Middle Initial & Last Name & Degree

Francois B Asseman, Dr

Phone

020-8383

Ext

5525

f.asseman@imperial.ac.uk

First Name & Middle Initial & Last Name & Degree

Michael A Gresty, Pr

First Name & Middle Initial & Last Name & Degree

Francois B Asseman, Dr

12. IPD Sharing Statement

Links:

URL

http://www1.imperial.ac.uk/medicine/about/divisions/neuro/npmdepts/clinneuroscience/movandbal/otology/mbprosthesis/

Description

Related Info

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Use of a Vibrotactile Sensory Prosthesis in Patients With Postural Imbalance and Spatial Disorientation

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