A Pilot Study Evaluating the BrainPort Balance Device to Improve Postural Control in Individual’s with Balance and Vestibular-Cerebellar Disorders Secondary to Stroke
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Status:
No longer recruiting. The abstracts have been submitted to the AAP and the APTA annual conferences, but have not yet been approved for presentation.
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.
Interventions:
Electrotactile Stimulation
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).
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Physical therapy
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Location(s):
Indiana
U.S.A.
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 plateau and has been discharged from physical therapy; no current oral health problems.
Exclusion Criteria
History of seizures; implanted electrical medical device (i.e. pacemaker); pregnancy.
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).
Primary Outcome:
Berg Balance Scale; Dynamic Gait Index; Stroke Impact Scale;
Activities-specific Balance Confidence Scale; Timed Up and Go
Results:
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. Due to lack of control subjects, we cannot conclusively state the differences observed here are solely attributed to the BPBD. The lack of statistical significance in TUG times could be explained by the variety of assistive devices used by the subjects.
Variability with individual compliance in the home
intervention phase may have also impacted the results.
These findings encourage the further study of BPBD as a
device for facilitating balance deficits secondary to stroke.
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Source of Information:
Wicab Inc.
Rehabilitation Hospital of Indiana
Mehta S, Badke MB, Deshpande N, Deutsch S, Burleigh Jacobs A, Malec J, Sherman J, Wasserman J, Yaron J, Dave S. The Effects of the BrainPort Balance Device on Measured as Well as Perceived Balance and Gait in Individuals with Balance Impairments due to Stroke. Poster session presented at: Association of Academic Physiatrists Annual Meeting; 2009 Feb 24-28; Colorado Springs, CO.
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Web Links and Publications:
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This information last updated on: 11/20/2009
Reviewed on: 11/20/2009.
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