A Substitute Vestibular Information System Using the BrainPort Device for Adults with Chronic Vestibular Dysfunction Following Stroke
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Status:
No longer recruiting. The abstracts have been submitted to the AAP and the APTA annual conferences. A poster presentation was excepted for AAP (Assoc of Academic Physiatrists) conference in Feb 2009 with the preliminary results of the study. There are no other published results as of yet.
Purpose:
To evaluate the safety and effectiveness of the BrainPort balance device, an investigational medical device, in treating patients with balance deficits following a stroke.
Year Started:
2007
Year Finished:
2008
Year Presented:
2009
Design:
Multi-center, pilot study, interventional.
Inclusion Criteria
Documented diagnosis of a stroke, at least 3 months ago; have reached a plateu and has been discharged from physical therapy; no current oral health problems; current balance problem; able to ambulate with or without assistance.
Exclusion Criteria
History of seizures; implanted electrical medical device (i.e. pacemaker); pregnancy.
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).
Primary Outcome:
Berg Balance Scale; Dynamic Gait Index; Stroke Impact Scale; Activities-specific Balance Confidence Scale; Timed Up and Go.
Results:
Preliminary results of the study:
1. Results reveal statistically significant improvements in
objective as well as subjective balance and gait in individuals
with balance impairment secondary to stroke after 8 weeks
of BPBD training.
2. Due to lack of control subjects, we cannot conclusively state
the differences observed here are solely attributed to the
BPBD.
3. The lack of statistical significance in TUG times could be
explained by the variety of assistive devices used by the
subjects.
4. Variability with individual compliance in the home
intervention phase may have also impacted the results.
5. These findings encourage the further study of BPBD as a
device for facilitating balance deficits secondary to stroke.
Source of Information:
Wicab, Inc.
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This information last updated on: 5/26/2009
Reviewed on: 10/19/2009.
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