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Sensor-supported Classification of Gait Patterns in Everyday Movement of Patients With Parkinson's Disease (PD-GPC)

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ClinicalTrials.gov Identifier: NCT04054856
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Medical Information Technology (MedIT), RWTH Aachen University
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
Within this study we conduct long-term measurements on Parkinson patients using a three sensor IMU setup: one sensor is located at the wrist, one sensor at the belt/ in the pocket and one sensor is worn as a pendant. Before and after each long-term measurement phase (5 days within 6-8 weeks) we perform an UPDRS to identify changes in everyday life behaviour that correlate with UPDRS trends (especially part 3).

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Body Sensor Network Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sensor-supported Classification of Gait Patterns in Everyday Movement of Patients With Parkinson's Disease
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients with Morbus Parkinson Device: Body Sensor Network
The "Integrated Posture and Activity NEtwork by Medit Aachen (IPANEMA)" Body Sensor Network (BSN) is a wireless sensor network with several sensor nodes. A sensor node consists of a base unit equipped with different sensor modalities: Acceleration sensor, Rotation rate sensor, Air pressure sensor, Photoplethysmography (PPG, optional), Galvanic Skin Response (GSR, optional) measurement. The sensor data is transmitted via a wireless 433/868 MHz ISM band radio link to the central radio node. From there, the data is transferred via a Bluetooth connection to a laptop or PC for processing. Three sensors are attached 1) to the wrist with a flexible Velcro strap, 2) hung around the neck on a specially designed collar and 3) worn loosely in the trouser pocket without further fixation or at the belt. The respective sensors are located in a closed, ergonomically shaped housing (size 70x40x20mm^3, approx. 35g) and have no electrically conductive contact to the skin surface of the test person.

Healthy Subjects Device: Body Sensor Network
The "Integrated Posture and Activity NEtwork by Medit Aachen (IPANEMA)" Body Sensor Network (BSN) is a wireless sensor network with several sensor nodes. A sensor node consists of a base unit equipped with different sensor modalities: Acceleration sensor, Rotation rate sensor, Air pressure sensor, Photoplethysmography (PPG, optional), Galvanic Skin Response (GSR, optional) measurement. The sensor data is transmitted via a wireless 433/868 MHz ISM band radio link to the central radio node. From there, the data is transferred via a Bluetooth connection to a laptop or PC for processing. Three sensors are attached 1) to the wrist with a flexible Velcro strap, 2) hung around the neck on a specially designed collar and 3) worn loosely in the trouser pocket without further fixation or at the belt. The respective sensors are located in a closed, ergonomically shaped housing (size 70x40x20mm^3, approx. 35g) and have no electrically conductive contact to the skin surface of the test person.




Primary Outcome Measures :
  1. Disease Assessment with Wearable Movement Sensors [ Time Frame: 5 days -12 weeks ]
    The Unified Parkinson's Disease Rating Scale (UPDRS) will be conducted in two consecutive clinical visits (6-12 weeks) or during an inpatient stay (5 days+). In between we conduct 5 days of long-term monitoring for each patient using a wearable movement sensor system. Outcome measures of the system (overall activity, stride time, stride variability, gait symmetry, symptom appearance, etc.) will be correlated with the UPDRS trend.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria Patients:

  1. patients with Parkinson's disease
  2. patients undergoing outpatient or inpatient treatment at the UKA
  3. age of majority (age > 60 years)
  4. written declaration of consent
  5. persons who are legally competent and mentally able to follow the instructions of the study personnel

Inclusion Criteria Healthy Volunteers:

  1. subjects of advanced age without neurological, psychiatric or other relevant internal diseases (age > 60 years)
  2. age of majority
  3. written declaration of consent
  4. persons who are legally competent and mentally able to follow the instructions of the study staff

Exclusion Criteria (general):

  1. persons with currently known instabilities of the musculoskeletal system (high fall potential)
  2. persons with electrophobia (fear of electrical devices)
  3. persons wearing electrically active implants (e.g. cardiac or brain pacemakers)
  4. persons with neurological (except PD) or psychiatric disorders
  5. persons with relevant internal diseases (e.g. severe heart failure)
  6. persons who are accommodated in an establishment on official or judicial instruction
  7. persons who are dependent on or have an employment relationship with the sponsor or investigator
  8. simultaneous participation in another interventional clinical trial
  9. alcohol or drug abuse
  10. lack of compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054856


Contacts
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Contact: Markus Lüken +49 241 8013515 lueken@hia.rwth-aachen.de

Locations
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Germany
Department of Neurology, University Hospital Aachen Recruiting
Aachen, North Rhine Westphalia, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Medical Information Technology (MedIT), RWTH Aachen University
Investigators
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Principal Investigator: Kathrin Reetz, Prof. Dr. Departmet of Neurology, University Clinic Aachen, Germany

Publications:
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT04054856     History of Changes
Other Study ID Numbers: 17-041
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases