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Wearable device and TUG paradigm based Parkinson's disease Study of early digital biomarkers

Wearable device and TUG paradigm based Parkinson's disease Study of early digital biomarkers

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072334
Enrollment
Unknown
Registered
2023-06-09
Start date
2023-10-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Parkinson‘disease

Interventions

Parkinson's disease patient:none
health control:none

Sponsors

Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: PD enrollment criteria 1. Must give informed consent to the trial and voluntarily sign a written informed consent form, be able to maintain good communication with the investigator and comply with the various requirements of the clinical trial; 2. Subjects must be 40-75 years of age (including borderline values) at the time of screening, with no restriction on gender. 3. Meet the International Parkinson and Movement Disorders Society (MDS) diagnostic criteria for primary Parkinson's disease, which are based on a primary symptom of one by one motor slowing, plus at least one of the following symptoms: resting tremor, myotonia, and the absence of any other known or suspected cause of Parkinson's syndrome; 4. Hoehn-Yahr scale = 25; Enrollment criteria for healthy subjects 1. Healthy non-PD population; 2.Subjects aged 40-75 years (including borderline values) at the time of screening, regardless of gender. 3.Must give informed consent to the trial, voluntarily sign a written informed consent form, be able to maintain good communication with the investigator and comply with the requirements of the clinical trial.

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria shall not be enrolled in this study: 1. various secondary Parkinsonian syndromes (including traumatic, pharmacogenetic, neoplastic, vascular, toxic, hydrocephalus, etc.) and Parkinsonian superimposed syndrome; 2. other diseases that cause gait disorders, including injuries to the joint parts of the spine, muscle spasms, strokes, peripheral neuropathies, muscle diseases, hydrocephalus and cognitive disorders; 3. significant cognitive impairment (MMSE score) illiteracy = 17; elementary school (= 6 years of education) = 20; secondary school or above (> 6 years of education) = 24; 4. with vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumor, unstable condition and other serious medical diseases 5. those with serious behavioral problems or mental disorders. 6. Anyone else who, in the opinion of the investigator, needs to be excluded.

Design outcomes

Primary

MeasureTime frame
Mini-mental State Examination;Montreal Cognitive Assessment;The 39-Item Parkinson's Disease Questionnaire;Hamilton Depression Rating Scale;hoehn-yahr stage;Movement Disorder Society-Sponsored Revision Of The Unified Parkinson's Disease Rating Scale;Wearable devices measure gait parameters;

Countries

China

Contacts

Public ContactQinyong Ye

Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital

unionqyye@163.com+86 591 8335 7896

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026