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NCT00146952 Clinical Trial

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

Proprioceptive Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00146952
Other study ID # DNMCA-PR1077
Secondary ID
Status Recruiting
Phase Phase 1
First received September 5, 2005
Last updated November 10, 2016
Start date January 2005
Est. completion date December 2007

Study information
Verified date September 2005
Source Imperial College London
Contact Michael A Gresty, Pr
Phone 020-8846
Email m.gresty@imperial.ac.uk
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- Sensory impairments

- Unsteadiness

Exclusion Criteria:

- High strokes

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Vibrotactile feedback

Locations
Country Name City State
United Kingdom Charing Cross Hospital London

Sponsors (2)
Lead Sponsor Collaborator
Imperial College London Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean time reaction to the perturbation with the feedback
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