Not provided
Not provided
Not provided
Not provided
Not provided
The study protocol needed to be modified
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open-label study to evaluate the effect of SpotOn balance glasses in non-demented Parkinson's patients with balance disorders.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpotOn Balance | Experimental | SpotOn Balance Glasses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpotOn balance glasses | Device | SpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's disease rating scale | 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). | 3 weeks |
| TIMED UP AND GO (TUG) | 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. | 3 weeks |
| Berg Balance Scale (BBS) | 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. | 3 weeks |
| Non-Motor Symptoms Scale (NMSS) | 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. | 3 weeks |
| 39-item Parkinson's Disease Questionnaire (PDQ-39) | 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. | 3 weeks |
| Freeze of gait (FOG) Questionnaire |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ilana Shlezinger, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAMBAM Health centre | Haifa | Israel |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Consists of 16 items assessing freeze of gait. Total score ranges from 0 to 24, higher score corresponds to more severe FOG. |
| 3 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |