Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

NCT00889824 | Completed Phase 1 Results

• 2 other identifiers: 09-06001R43DC010080-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Dizziness

Keywords

Chronic imbalance; vestibular disorders; balance prosthesis

Outcome Measures

Primary Outcomes (1)

• Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.

  The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24.

  6 weeks

Study Arms (1)

prosthesis group

EXPERIMENTAL

balance prosthesis

Device: balance prosthesis

Interventions

balance prosthesis DEVICE

vibrotactile stimulation

prosthesis group

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory patients who have had chronic imbalance for at least one year, and have reached a functional performance plateau with respect to their balance adaptation.

You may not qualify if:

• Neurological disorders other than chronic balance disorders, as determined by medical history and neurological screening procedure.
• Any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests.
• Peripheral neuropathies of the lower extremities.
• Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Barron Associates, Inc.: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joel Goebel, MD
• Organization: WashingtonU

goebelj@ent.wustl.edu

(314) 362-7344

Study Officials

• Joel A Goebel, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 15, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-01

Locations

US (1)