Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke

Completed

Phase N/A Results N/A

Trial Description

The purpose of this study is to evaluate the safety and efficacy of the BrainPort balance device in improving balance in people with balance deficits due to stroke.

Detailed Description

Following baseline assessments, subjects participate in 5 consecutive days (10 hours) of clinic training with the BrainPort balance device with a Physical Therapist. Assessments are repeated at the end of clinic training. Following clinic training, subjects take the device home to use for two (2) 20 minute training sessions each day. Subjects return to the clinic for one (1) day of testing after using the device at home for 7 weeks.

Conditions

Interventions

  • BrainPort Balance Device Device
    Intervention Desc: The BrainPort balance device, is a non-invasive medical device that provides head and body position information to a person via their tongue.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

Patients will participate in BrainPort training sessions for 2 1-hour sessions with a Physical Therapist daily for 5 consecutive days in the clinic and will afterwards continue training for 2-20 minute sessions each day at home for 7 weeks. 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.
Primary Dynamic Gait Index baseline, 5 days, end of study No
Primary Berg Balance Scale Baseline, 5 days, end of study No
Primary Activities-specific Balance Confidence Scale Baseline, 5 days, end of study No
Primary Timed Up and Go Baseline, 5 days, end of study No
Primary Stroke Impact Scale Baseline, 5 day, end of study No

Sponsors