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| Name | Class |
|---|---|
| Istanbul University | OTHER |
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Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes |
|
| Active Stimulation | Experimental | Instrinsic auricular muscles will be stimulated for 20 minutes |
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| Sham | Sham Comparator | An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes |
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| Passive Control | No Intervention | Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro-stimulation | Device |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the UPDRS Motor Score (Part III) | Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation | 10 minutes after the stimulation is initiated. |
| Change in the UPDRS Motor Score (Part III) | Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated. | 30 minutes after the stimulation is terminated. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the gait and balance parameters (cadence) | cadence | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters (Stride length) | Stride length in meters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University | Istanbul | Turkey (Türkiye) | ||||
| Koc University Hospital |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Other |
|
| 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters (Stride velocity) | Stride velocity in m/s | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Arm Swing Rate | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Arm Range of Motion | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Sit to Stand Duration | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Sit to Stand Peak Trunk Velocity | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Sit to Stand Peak Trunk Angle | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Leg Swing Rate | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Leg Range of Motion | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Turn to Sit Peak Turn Velocity | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Turn-to-Sit Trunk Range of Motion in Sagittal Plane | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Knee Range of Motion | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters | Trunk Joint Angles | 10 minutes after the stimulation is initiated. |
| Change in the gait and balance parameters (cadence) | cadence | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters (Stride length) | Stride length in meters | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters (Stride velocity) | Stride velocity in m/s | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Arm Swing Rate | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Arm Range of Motion | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Sit to Stand Duration | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Sit to Stand Peak Trunk Velocity | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Sit to Stand Peak Trunk Angle | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Leg Swing Rate | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Leg Range of Motion | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Turn-to-Sit Peak Turn Velocity | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Turn-to-Sit Trunk Range of Motion | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Knee Range of Motion | 30 minutes after the stimulation is terminated. |
| Change in the gait and balance parameters | Trunk Joint Angles | 30 minutes after the stimulation is terminated. |
| Istanbul |
| Turkey (Türkiye) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |