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This investigation is undertaken to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paragit | Experimental | Sleeve to quantify symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paragit | Device | Sleeve to quantify symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tremor | Tremor will be assessed using the device, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied. | During the clinical assessment, and for the following 24h. |
| Bradykinesia | Bradykinesia will be assessed using the device, measured inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied. | During the clinical assessment, and for the following 24h. |
| Rigidity | The device will assess rigidity, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied. | During the clinical assessment, and for the following 24h. |
| Dyskinesia | The device will assess rigidity, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied. | During the clinical assessment, and for the following 24h. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety of the Paragit Sleeve by assessment of device deficiencies and adverse events, non-serious and serious, rated for causality. | During the clinical assessment , and for the following 24h. |
| Usability |
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Inclusion Criteria:
Parkinson disease: Clinically diagnosed
Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49)
Experiencing at least two of following symptoms and/or side effect on a daily basis:
Provision of informed consent, i.e., the subject must be able to:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Beata MarĂa Ana | Recruiting | Madrid | Spain |
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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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The usability of the device will be studied using a questionnaire.
| During the clinical assessment , and for the following 24h. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |