A Pilot Study Evaluating the BrainPort Balance Device to Improve Postural Control in Individual’s with Balance and Vestibular-Cerebellar Disorders Secondary to 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

  • Physical therapy Other
  • Electrotactile Stimulation (BrainPort)Procedure/Surgery
    Intervention Desc: Electrotactile stimulation for sensory substitution communicates non-tactile information via electrical stimulation of the sense of touch to the brain (that is, an array of electrodes receiving input from a non-tactile information source such as a camera, applies small, controlled, painless currents to the skin at precise locations according to an encoded pattern. The encoding of the electrical pattern essentially attempts to mimic the input that would normally be received by the non-functioning sense).

Trial Design

Multi-center, pilot study; Interventional.

Patient Involvement

Active participation in BrainPort training sessions with a Physical Therapist for two 1-hour sessions daily 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