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.
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.
- 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.
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Single Group Assignment
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).
|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|
- Wicab Lead