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Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability (BALCAP)

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ClinicalTrials.gov Identifier: NCT03330262
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Barron Associates, Inc.

Brief Summary:
The goal of this study is to evaluate a tactile prosthesis that provide individuals who have demonstrated chronic imbalance with help to maintain a correct sense of orientation with respect to the gravity and improve posture control.

Condition or disease Intervention/treatment Phase
Vestibular Disorder Dizziness Device: BALCAP prosthesis Not Applicable

Detailed Description:

The goal of this study is to evaluate a tactile prosthesis that provide individuals who have demonstrated chronic imbalance with help to maintain a correct sense of orientation with respect to the gravity and improve posture control. Chronic imbalance leads to significant problems. This study is designed to evaluate a device which can potentially improve the balance of these patients.

The participant will be asked to come to Washington University on two occasions (pre- and post-trial) for approximately 2 hours. Between visits, they will be asked to use the device daily (intervention group) or to not use the device (control group) for a prescribed period of time doing different activities. They will be provided written instructions from a physical therapist that will be determined by their individual ability. The activities will be typical exercises that are given to people with balance disorders.

On their first visit (week 1) participants will be asked to complete the same kind of tests that evaluated the function of their balance system at the time of their diagnosis. They will have their eye movements recorded using goggles and an infra-red camera while the prosthesis is in place and providing vibration feedback. Computerized Dynamic Posturography (CDP) testing will require them to stand on a platform and perform tests (20 seconds each) with their eyes open or closed, with the platform moving or still, and/or with the visual surround either stable or moving. They will be fitted with a safety harness that will keep them from falling. Next the investigators will evaluate their ability to perform movement tasks while walking (walking down the hall, walking down the hall avoiding objects, changing speeds while walking, going up and down stairs etc). They will walk a 25-foot distance at a comfortable gait speed, and again at a maximum gait speed. Lastly, they will be asked to fill out questionnaires.

On their last visit they will repeat the evaluations that were performed during the first visit.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: BALCAP prosthesis
Participants will be asked to perform a series of appropriate exercises daily at home wearing the BALCAP prosthesis for a period of 6 weeks. The training exercises will include: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, incorporating turns and movements other than straight forward walking, eyes open.
Device: BALCAP prosthesis
The noninvasive BALCAP prosthesis offers uses six degrees-of-freedom (6-DOF) sensing to detect postural imbalance and actuate low-amplitude vibrotactile cues directly to the head to provide the wearer with feedback concerning head tilt in the pitch and roll plane.
No Intervention: Control
Participants will be asked to perform a series of appropriate exercises daily at home for a period of 6 weeks. The training exercises will include: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, incorporating turns and movements other than straight forward walking, eyes open.



Primary Outcome Measures :
  1. Change in DGI [ Time Frame: At beginning of study and after 6 weeks of home use ]
    Change in Dynamic Gait Index


Secondary Outcome Measures :
  1. Change in CDP [ Time Frame: At beginning of study and after 6 weeks of home use ]
    Change in Computerized Dynamic Posturography

  2. Change in Gait Speed [ Time Frame: At beginning of study and after 6 weeks of home use ]
    Change in Gait speed analysis over a 25-foot test distance

  3. Change in ABC Scale [ Time Frame: At beginning of study and after 6 weeks of home use ]
    Change in Activities-specific Balance Confidence (ABC) Scale

  4. Change in DHI Questionnaire [ Time Frame: At beginning of study and after 6 weeks of home use ]
    Change in Dizziness Handicap Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory
  • Chronic imbalance for at least 1 year
  • Have reached a functional performance plateau with respect to balance performance
  • Have a DGI score of <19
  • Fall below age and gender matched normative data for gait speed

Exclusion Criteria:

  • 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.
  • Women who are pregnant (women will self-report possible pregnancy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330262


Contacts
Contact: Belinda C Sinks, AUD 314-362-7546 sinksb@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Belinda C Sinks, AUD         
Sponsors and Collaborators
Barron Associates, Inc.
Washington University School of Medicine
Investigators
Principal Investigator: Eugene Parker, PHD Barron Associates, Inc.

Responsible Party: Barron Associates, Inc.
ClinicalTrials.gov Identifier: NCT03330262     History of Changes
Other Study ID Numbers: BALCAP1
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Barron Associates, Inc.:
Postural Instability
Balance Disorder
Balance Prosthesis
Dizziness

Additional relevant MeSH terms:
Dizziness
Vertigo
Vestibular Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases