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

November 5, 2020 updated by: Juha Puustinen, Satakunta Central Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Pori, Finland
        • Satakunta Central Hospital, Unit of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PD patients: early stage
Parkinson Disease patients with early stage of the disease: potentially hypokinesia, but no dyskinesia and motor fluctuations
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: developed stage
PD patients having dyskinesia and motor fluctuations (described as "developed stage of the 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)
No PD
Subjects not having diagnosed Parkinson Disease
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satakunta Central Hospital

Collaborators

Tampere University of Technology

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5137/31/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Anonymized 3-day motion data recordings.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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