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

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

Recruiting
50 years and older
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Parkinson Disease

NCT06490861

Paragit ApS

14 October 2025

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