Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses
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|ClinicalTrials.gov Identifier: NCT03942172|
Recruitment Status : Suspended (The study protocol needed to be modified)
First Posted : May 8, 2019
Last Update Posted : December 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: SpotOn balance glasses||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses|
|Actual Study Start Date :||November 27, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: SpotOn Balance
SpotOn Balance Glasses
Device: SpotOn balance glasses
SpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses
- Unified Parkinson's disease rating scale [ Time Frame: 3 weeks ]A comprehensive 50 question clinical rating scale for the assessment of both motor and non-motor symptoms associated with Parkinson's. The total cumulative score will range from 0 (no disability) to 199 (total disability).
- TIMED UP AND GO (TUG) [ Time Frame: 3 weeks ]The TUG test is a physical performance measure in which the ability to rise up from a seated chair position, walk 3m, turn, walk back, and sit down is timed.
- Berg Balance Scale (BBS) [ Time Frame: 3 weeks ]The BBS is a widely used clinical test of a person's static and dynamic balance abilities. t is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.A score of 56 indicates functional balance.
- Non-Motor Symptoms Scale (NMSS) [ Time Frame: 3 weeks ]The non-motor symptoms questionnaire is a 30-point, patient-based questionnaire used to determine the non-motor symptoms experienced by the patient during the past month.Responses quantify symptoms according severity (using a scale of 0-3) and frequency (using a scale of 0-4). Higher scores represent more severe and more frequent symptoms.
- 39-item Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: 3 weeks ]This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. It is scored on a scale of 0-100, with lower scores indicating better health and high scores more severe symptoms.
- Freeze of gait (FOG) Questionnaire [ Time Frame: 3 weeks ]Consists of 16 items assessing freeze of gait. Total score ranges from 0 to 24, higher score corresponds to more severe FOG.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942172
|RAMBAM Health centre|
|Principal Investigator:||Ilana Shlezinger, MD||Rambam Hospital|