Use of a Vibrotactile Sensory Prosthesis in Patients With... | NCT00146952

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

NCT00146952

Sponsor

Imperial College London

Status

Unknown status

Last Update Posted

Nov 11, 2016Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Vestibular Diseases
Peripheral Neuropathies
Proprioceptive Disorders
Hemispatial Neglect

Interventions

Vibrotactile feedback

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Dec 2007

First Submitted Date

Sep 5, 2005

First Submission Date that Met QC Criteria

Sep 5, 2005

First Posted Date

Sep 7, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2016

Last Update Posted Date

Nov 11, 2016Estimated

Name	Class
Medical Research Council	OTHER_GOV

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
Vibrotactile feedback	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean time reaction to the perturbation with the feedback

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sensory impairments
Unsteadiness

Exclusion Criteria:

High strokes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael A Gresty, Pr	Contact	020-8846	7634	m.gresty@imperial.ac.uk
Francois B Asseman, Dr	Contact	020-8383	5525	f.asseman@imperial.ac.uk

Overall Officials

Name	Affiliation	Role
Michael A Gresty, Pr	Imperial College London	Principal Investigator
Adolfo M Bronstein, Pr, MD	Imperial College London	Study Director
Christopher Kennard, Pr, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charing Cross Hospital	Recruiting	London		W6 8RF	United Kingdom

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D015837	Vestibular Diseases
D010523	Peripheral Nervous System Diseases
D020886	Somatosensory Disorders
D010468	Perceptual Disorders

Ancestor Terms

ID	Term
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided