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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
Sponsored by
Imperial College London
About
Eligibility
Locations
Outcomes
Full info

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

First Posted
September 5, 2005
Last Updated
November 10, 2016
Sponsor
Imperial College London
Collaborators
Medical Research Council
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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
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
Email
m.gresty@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Francois B Asseman, Dr
Phone
020-8383
Ext
5525
Email
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
Email
m.gresty@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Francois B Asseman, Dr
Phone
020-8383
Ext
5525
Email
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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