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

• ClinicalTrials.gov Identifier: NCT03330262
• Recruitment Status: Completed
• First Posted: November 6, 2017
• Last Update Posted: February 25, 2019
• Sponsor: Barron Associates, Inc.
• Collaborator: Washington University School of Medicine
• Information provided by (Responsible Party): Barron Associates, Inc.

Tracking Information

• First Submitted Date: May 11, 2017
• First Posted Date: November 6, 2017
• Last Update Posted Date: February 25, 2019
• Actual Study Start Date: October 1, 2017
• Actual Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• Vestibular Disorder
• Dizziness

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2019): 16
• Original Estimated Enrollment (submitted: November 1, 2017): 50
• Actual Study Completion Date: November 30, 2018
• Actual Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03330262
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Barron Associates, Inc.
• Study Sponsor: Barron Associates, Inc.
• Collaborators: Washington University School of Medicine

Investigators

• Principal Investigator: Eugene Parker, PHD; Barron Associates, Inc.

• PRS Account: Barron Associates, Inc.
• Verification Date: February 2019