Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

NCT03330262 | Completed Results FDA Device

• 1 other identifier: BALCAP1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Disorder; Dizziness

Keywords

Postural Instability; Balance Disorder; Balance Prosthesis; Dizziness

Outcome Measures

Primary Outcomes (1)

• Difference in Dynamic Gait Index (DGI)

  This outcome compared the Dynamic Gait Index score when the BALCAP prosthesis was worn vs. when it was not worn at baseline in order to evaluate if there is an assistive benefit to wearing the device. The Dynamic Gait Index (DGI) is a clinical tool to assess gait, balance, and fall risk using various walking tasks. The range of scores is 0 to 24. A higher score is better. All participants performed this test at baseline both wearing the BALCAP and not wearing the BALCAP. This test does not measure a change in DGI score over time but compares the results of the test while wearing the BALCAP vs. not wearing the BALCAP during the same evaluation period (baseline).

  Week 0 (baseline)

Secondary Outcomes (4)

• Change in Computerized Dynamic Posturography: Equilibrium Score

  Before and after 6 weeks of either the intervention or the control condition

• Difference in Gait Speed

  Week 0 (baseline)

• Change in Activities-specific Balance Confidence (ABC) Scale

  Before and after 6 weeks of either the intervention or the control condition

• Change in Dizziness Handicap Inventory Score

  Before and after 6 weeks of either the intervention or the control condition

Study Arms (2)

BALCAP prosthesis, then Control

EXPERIMENTAL

Participants performed exercises daily at home wearing the BALCAP prosthesis for 6 weeks. After 6 weeks, participants performed the control condition (the same exercises without the BALCAP). Tests were performed before and after each 6-week period. Exercises included: (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, with turns and movements other than straight forward walking, eyes open.

Device: BALCAP prosthesis

Control, then BALCAP prosthesis

EXPERIMENTAL

Participants performed exercises daily at home for 6 weeks without wearing the BALCAP prosthesis (control), followed by another 6 weeks of the same exercises with the BALCAP prosthesis (intervention). Tests were performed before and after each 6 week period. Exercises included: (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, with turns and movements other than straight forward walking, eyes open.

Device: BALCAP prosthesis

Interventions

BALCAP prosthesis DEVICE

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.

BALCAP prosthesis, then Control; Control, then BALCAP prosthesis

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Barron Associates, Inc.: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Vestibular Diseases; Dizziness

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Principal Research Scientist
• Organization: Barron Associates

barron@barronassociates.com

434-973-1215

Study Officials

• Eugene Parker, PHD

  Barron Associates, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: November 6, 2017
• Study Start: October 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: March 10, 2021
• Results First Posted: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)