An Open Multi-centre Investigation to Evaluate the Performance of the Paragit Sleeve With build-in sEMG Sensors, Kinetic Sensors, and Smart-textile to Measure and Monitor Motor Symptoms and Treatment-induced Dyskinesia in Patients With Parkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Paragit ApS
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Dyskinesia
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This investigation is undertaken to:
- Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and
- To assess the safety and tolerability of the device in patients with PD.
Investigators
Eligibility Criteria
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:
- •Bradykinesia
- •Dyskinesia (treatment side effect)
- •Provision of informed consent, i.e., the subject must be able to:
- •Read and understand the Patient Information and Consent Form
- •Sign the Patient Information and Consent Form.
Exclusion Criteria
- •Known allergy/hypersensitivity to any material in direct contact with the skin (stainless steel, silicone and polyester)
- •Other neurological diseases
Outcomes
Primary Outcomes
Dyskinesia
Time Frame: During the clinical assessment, and for the following 24h.
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.
Tremor
Time Frame: During the clinical assessment, and for the following 24h.
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.
Bradykinesia
Time Frame: During the clinical assessment, and for the following 24h.
Bradykinesia will be assessed using the device, measured inertial measurement unit \[m/s2\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Rigidity
Time Frame: During the clinical assessment, and for the following 24h.
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.
Secondary Outcomes
- Usability(During the clinical assessment , and for the following 24h.)
- Safety(During the clinical assessment , and for the following 24h.)