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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330262
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Barron Associates, Inc.

Tracking Information
First Submitted Date  ICMJE May 11, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
Change in DGI [ Time Frame: At beginning of study and after 6 weeks of home use ]
Change in Dynamic Gait Index
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
  • Change in CDP [ Time Frame: At beginning of study and after 6 weeks of home use ]
    Change in Computerized Dynamic Posturography
  • 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
  • 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
  • Change in DHI Questionnaire [ Time Frame: At beginning of study and after 6 weeks of home use ]
    Change in Dizziness Handicap Inventory
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Official Title  ICMJE Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Vestibular Disorder
  • Dizziness
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: BALCAP prosthesis
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2019)
16
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2017)
50
Actual Study Completion Date  ICMJE November 30, 2018
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330262
Other Study ID Numbers  ICMJE BALCAP1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barron Associates, Inc.
Study Sponsor  ICMJE Barron Associates, Inc.
Collaborators  ICMJE Washington University School of Medicine
Investigators  ICMJE
Principal Investigator: Eugene Parker, PHD Barron Associates, Inc.
PRS Account Barron Associates, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP