A Substitute Vestibular Information System Using the BrainPort Device for Adults with Chronic Vestibular Dysfunction Following Stroke

Completed

Phase N/A Results

Trial Description

To evaluate the safety and effectiveness of the BrainPort balance device, an investigational medical device, in treating patients with balance deficits following a stroke.

Interventions

Trial Design

Multi-center, pilot study, interventional.

Patient Involvement

Active participation in BrainPort training sessions for 2 1-hour sessions for 5 consecutive days in the clinic. Continue training for 2-20 minute sessions each day at home for duration of study. Assessments completed at baseline, 5 days and at end of study (8 weeks).

Outcomes

Type Measure Time Frame Safety Issue
Primary Berg Balance Scale; Dynamic Gait Index; Stroke Impact Scale; Activities-specific Balance Confidence Scale; Timed Up and Go.

Sponsors

Wicab, Inc. Middleton, WI