Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With Parkinson's Disease

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06490861

Acronym

PARPIV23

Enrollment

Registered

2024-07-08

Start date

2023-12-19

Completion date

2024-12-31

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

DEVICEParagit

Sleeve to quantify symptoms

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Parkinson disease: Clinically diagnosed 2. Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49) 3. Experiencing at least two of following symptoms and/or side effect on a daily basis: * Rigidity * Tremor * Bradykinesia * Dyskinesia (treatment side effect) 4. 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

1. Known allergy/hypersensitivity to any material in direct contact with the skin (stainless steel, silicone and polyester) 2. MMSE \<24 3. Other neurological diseases

Design outcomes

Primary

Measure	Time frame	Description
Tremor	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	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	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.
Dyskinesia	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

Measure	Time frame	Description
Safety	During the clinical assessment , and for the following 24h.	Safety of the Paragit Sleeve by assessment of device deficiencies and adverse events, non-serious and serious, rated for causality.
Usability	During the clinical assessment , and for the following 24h.	The usability of the device will be studied using a questionnaire.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026