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Identification of Motor Symptoms Related to Parkinson's Disease Using Motion Tracking Sensors at Home (KÄVELI)

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ClinicalTrials.gov Identifier: NCT03366558
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Tampere University of Technology
Information provided by (Responsible Party):
Juha Puustinen, Satakunta Central Hospital

December 4, 2017
December 8, 2017
April 19, 2018
March 27, 2018
December 31, 2018   (Final data collection date for primary outcome measure)
  • Accuracy of the classification of data from movement sensors in relation to the detected motor symptoms [ Time Frame: 3 days ]
    Accuracy and consistency of the classification of the subjects in the 3 categories (early stage disease, developed stage of disease, no disease) based on movement signals recorded with accelerometers and gyroscopes. Sensitivity and specificity of the classification are analyzed. Several features and methods of classification are tested including time-domain features, time-frequency domain features and machine learning both from raw data and calculated feature sets.
  • Accuracy of the detection of the time when the Parkinson medicine was taken [ Time Frame: 3 days ]
    Accuracy and consistency of detecting the time when the medicine is taken based on movement signals recorded with accelerometers and gyroscopes. Sensitivity and specificity of the detection are analyzed. Several features and methods of analysis are tested including time-domain features, time-frequency domain features and machine learning both from raw data and calculated feature sets.
Same as current
Complete list of historical versions of study NCT03366558 on ClinicalTrials.gov Archive Site
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Identification of Motor Symptoms Related to Parkinson's Disease Using Motion Tracking Sensors at Home
Sensor-based Motion Characterization in Patients With Parkinson's Disease

Parkinson's disease (PD) is a chronic and progressive neurological movement disorder, meaning that symptoms continue and worsen over time. Nearly 10 million people worldwide are living with Parkinson's disease. Finding cost-effective non-invasive monitoring techniques for detecting motor symptoms caused by Parkinson's disease are potentially of significant value for improving care. Of the PD symptoms, the motor symptoms are the most common and detectable signs that can be assessed unobtrusively for both diagnosis and for evaluating the effectiveness of the treatments.

The goal of our study is to find methods for identifying and classifying the motor symptoms caused by Parkinson's disease. Focus of the study is on long-term motion tracking measurements conducted at home during normal everyday life. Both accelerometers connected to arm and leg and mobile phone inbuilt sensors carried in the belt are utilized in the study. The research has two main objectives / hypotheses:

  1. Can the motor symptoms related to different levels of Parkinson's disease be identified using motion tracking sensors? The first objective includes extracting and screening the motion differences of patients in early stages of the diseases in comparison with the patients in developed stages (patients having hypokinesia, dyskinesia and state changes) of the diseases and their differences with healthy control elderly adults using advanced signal and data analytics. Data from questionnaires and walking test conducted in the hospital environment are utilized as comparison points. Goal is to test the hypothesis that the amount of motor symptoms can be detected and the three groups can be reliably separated using sensor data.
  2. Can the time when the Parkinson medicine is taken be detected from the movement signals?

A sample of 50 volunteer PD patients with early stage of the disease (no dyskinesia and state changes), plus 50 volunteer PD patients in the later stage of the disease (having dyskinesia and state changes), plus 50 volunteers who do not have Parkinson's disease will be recruited for the research.

Study starts with a telephone screening and visit to the hospital. Background characteristics and stage of the Parkinson's disease is evaluated in the hospital using a UPDRS questionnaires (Unified Parkinson's Disease Rating Scale; Finnish version) and a standardized 20-step walking test. Before the walking test, accelerometer sensors are attached to the shank and on the nondominant wrist. In addition, the participant wears a smart mobile phone with embedded accelerometer and gyroscope sensors. Based on the questionnaires and walking test study physiotherapist classifies the participant into one of the three study groups.

The major part of the study involves a 3-day motion screening in a free-living setting in which the subjects are wearing the abovementioned sensors for as long duration as they comfortably can and are willing. This 3-day study starts immediately after completion of the 20-step walking test in the hospital. During the 3-day study, subjects are free to live their lives without any additional tests. Subjects mark down the time when they take their Parkinson medication.

Not Provided
Observational [Patient Registry]
Observational Model: Case-Control
Time Perspective: Prospective
3 Days
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Non-Probability Sample

Patients having Parkinson's disease will be recruited with two methods: A) Unit of Neurology at Satakunta Central Hospital searches from the patient records potential participants, who have visited the hospital during the past 5 years with ICD-10 code G20. B) In case not enough participants are found from the Unit of Neurology, advertisements in local newspapers, in local Parkinson's disease patient association newsletters and in the web site of the hospital will be utilized.

For recruiting volunteers without Parkinson's disease into the reference group, an advertisement is placed in local newspapers and in the web pages of the hospital.

Parkinson Disease
  • Diagnostic Test: UPDRS questionnaires
    UPDRS (Unified Parkinson's Disease Rating Scale) questionnaires are utilized for the assessment of the disease stage.
  • Diagnostic Test: 20-step walking test
    20-step walking test is utilized either for assessing the disease stage (subjects having Parkinson disease) or for assessing the normal walking (subjects not having Parkinson disease)
  • PD patients: early stage
    Parkinson Disease patients with early stage of the disease: potentially hypokinesia, but no dyskinesia and motor fluctuations
    Interventions:
    • Diagnostic Test: UPDRS questionnaires
    • Diagnostic Test: 20-step walking test
  • PD patients: developed stage
    PD patients having dyskinesia and motor fluctuations (described as "developed stage of the disease")
    Interventions:
    • Diagnostic Test: UPDRS questionnaires
    • Diagnostic Test: 20-step walking test
  • No PD
    Subjects not having diagnosed Parkinson Disease
    Intervention: Diagnostic Test: 20-step walking test

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

(A) participants must be 30 years of age or older. (B) (for the Parkinson groups) diagnosed with PD (ICD-10 code G20) by a physician (neurologist or physician specializing in neurology). (C) They should be able to walk at least 20 steps unassisted (subjects are allowed to get help from assistive devices but not from other persons).

Exclusion Criteria:

(A) The subjects must not be receiving any deep brain stimulation (DBS) treatment while they are participating, but intraduodenal administration of levodopa (Duodopa®) or intradermal administration of apomorphine (Apogo® or Dacepton®) is accepted. (B) .Other extrapyramidal syndromes such as MSA (multiple system atrophy), PSP (progressive supranuclear palsy), CBD (corticobasal degeneration), LBD (Lewy body dementia) or dopamine antagonist drug (such as antipsychotic drug, metoclopramide) induced Parkinsonism will be excluded.

Sexes Eligible for Study: All
30 Years and older   (Adult, Older Adult)
Yes
Contact: Juha Puustinen, MD, PhD +358 44 707 7806 juha.puustinen@satshp.fi
Contact: Terhi Pakkanen, physiotherapist terhi.pakkanen@satshp.fi
Finland
 
 
NCT03366558
5137/31/2016
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Plan Description: Anonymized 3-day motion data recordings.
Juha Puustinen, Satakunta Central Hospital
Satakunta Central Hospital
Tampere University of Technology
Study Chair: Jari Ruokolainen, PhD Tampere University of Technology
Study Director: Hannu Nieminen, PhD Tampere University of Technology
Study Director: Juha Puustinen, MD, PhD Satakunta Central Hospital
Satakunta Central Hospital
April 2018