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Parkinson DiseasePD-GPCNCT04054856

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

A study testing Body Sensor Network in people with Parkinson Disease, run by RWTH Aachen University at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Parkinson Disease
What is being tested?
Body Sensor Network
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteGermany
Study dates
16 Dec 2019to 6 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • patients with Parkinson's disease
  • patients undergoing outpatient or inpatient treatment at the UKA
  • age of majority (age > 60 years)
  • written declaration of consent
  • persons who are legally competent and mentally able to follow the instructions of the study personnel
  • subjects of advanced age without neurological, psychiatric or other relevant internal diseases (age > 60 years)
Show all 9Show fewer
  • age of majority
  • written declaration of consent
  • persons who are legally competent and mentally able to follow the instructions of the study staff

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Department of Neurology, University Hospital Aachen

    Aachen, North Rhine-Westphalia, 52074

Other trials in Germany

About this study

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).

Read the detailed description

The aim of the study is to collect a database for the development of algorithms for the classification of everyday movement patterns of PD patients with the underlying sensor concepts. From the recorded movement data of PD patients and healthy volunteers (reference basis), characteristic features will be derived which could allow a distinction between pathological and unobtrusive non-disturbed movement patterns (e.g. on/off-state classification) and an assessment of the fall potential.

Study Timeline

The present study will be carried out in three, partly successive stages. The first two stages are measurements with the presented system during a medical examination (or afterwards) under annotation of certain motor exercises to determine the state of health of the patient or test person. In order to generate a sufficient reference database of comparable movement patterns, a series of measurements with subjects of a similar average age is carried out in parallel with the same sensor configuration and the same motor exercises. The third part of the study includes measurements in the home environment of Parkinson's patients. These measurements are used to identify the previously annotated movement patterns in the everyday life of the patient of the same previously included patient group. The individual stages of the study comprise in detail:

  1. Acquisition of patients/test persons The voluntary participants of this study will be recruited during the doctor's visit. The group of study participants with PD may consist of both outpatients and inpatients with Parkinson's disease (see also sub-section 4). The group of healthy volunteers is recruited from relatives or acquaintances of the patients or by request of uninvolved persons (in each case without motor impairments, see inclusion/exclusion criteria). If a patient or subject is suitable to participate in the study based on the inclusion and exclusion criteria, he or she will be informed and sign the consent form so that he or she can be included in the study. Each study participant receives an individual identification number, which is used to identify all other patient-specific documents.
  2. Annotation Measurements Parkinson Patients As soon as the patients have agreed to voluntarily participate in the study, the current disease status is first determined during a medical examination on the basis of a UPDRS and documented for the study evaluation. Following this, typical exercises for recording motor deficits are carried out. For this purpose, the patient is equipped with the intended sensor system and instructed in its use. The sensor system comprises three different sensor nodes, which are placed around the wrist, as a collar and in the trouser pocket. The wrist sensor is fixed to the patient's wrist by a flexible strap with a Velcro fastener. The neck sensor is positioned under the upper layer of clothing and hung around the neck by means of a special textile collar (approx. 35g). The third sensor knot has no special fastening device and is carried loosely in the trouser pocket. The attachment of the sensors is illustrated in Fig. 1. The movement data are recorded parallel to the exercises and extensively annotated according to the exercise characteristics. The exercises contain typical everyday movement patterns, which are to be identified in the further course of the study in the measurements in the domestic environment (subitem 3) and used for the evaluation of the state of health. These include among others: sit-to-stand test (STS), five-times-sit-to-stand test (5STS), sit-to-walk test (STW) or timed-up-and-go test (TUG), normal walking, climbing stairs, and handwriting.
  3. Annotation measurements reference group The volunteers participating in the study will be equipped with the same measuring equipment as the group of Parkinson's patients. The measurements on subjects of comparable average age serve as a reference to physiological movement sequences during the same motor exercises. On the one hand, the aim is to cover as broad a spectrum as possible for the classification of the various movement patterns. On the other hand, the data are to be used to identify pathological features that distinguish them from healthy movement patterns.
  4. Movement monitoring in the domestic/clinical environment of patients The group of outpatient/inpatient Parkinson's patients also take part in a long-term measurement in the domestic/clinical environment. Following the first motor examination, 5 consecutive measurements over a longer period of one day each are carried out in this section of the study. The equipment with the required measuring electronics takes place at the patient's place of residence/ in the clinic. In addition to the three previously used sensor nodes, the patient is equipped with a further node for recording on an SD card, which is also carried in the trouser pocket (approx. 35g). The SD card is written using low-level access and an internally developed protocol. This prevents third parties from accessing the transaction data. The measuring equipment is handed over on the morning of the scheduled day by a co-investigator. The patient is equipped with the system and the necessary handling of the sensor nodes is explained over the course of the day. As a daily form dependent annotated reference, the motor exercises mentioned under 2. are repeated - as far as possible in the patient's home environment / in the clinic. The patient is asked to keep an event log of the day at his own discretion and ability. On the evening of the same day, the measuring system is received again on site by a co-investigator. Any complications or questions regarding the further study protocol will be received, documented and, if necessary, reported to the study director.
  5. Final motor examination After completion of the third part of the study, each participant undergoes a final medical examination. This will take place following the nearest routine visit. In this examination, the motor exercises are carried out again in order to establish a basis for comparison with the initial situation (UPDRS Trend).
Being tested
Body Sensor Network
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Body Sensor NetworkDevice

    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.

Study groups in NCT04054856
Study groupRoleWhat they receive
Patients with Morbus ParkinsonOtherNot described
Receives: Device: Body Sensor Network
Healthy SubjectsOtherNot described
Receives: Device: Body Sensor Network

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Assessment with Wearable Movement Sensors

    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.

    Measured: 5 days -12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2019
  2. Study start16 Dec 2019
  3. Primary completion20 Apr 2022
  4. Study completion6 Mar 2023

Why it stopped: Due to COVID-19 pandemic and new regulatory requirements

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04054856
Sponsor's protocol ID
17-041
Acronym
PD-GPC
Status last verified
Mar 2023
First submitted
2 Jul 2019
Last updated
3 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dennison AC, Noorigian JV, Robinson KM, Fisman DN, Cianci HJ, Moberg P, Bunting-Perry L, Martine R, Duda J, Stern MB. Falling in Parkinson disease: identifying and prioritizing risk factors in recurrent fallers. Am J Phys Med Rehabil. 2007 Aug;86(8):621-32. doi: 10.1097/PHM.0b013e311611583.

    PubMed 17667192
  • Pickering RM, Grimbergen YA, Rigney U, Ashburn A, Mazibrada G, Wood B, Gray P, Kerr G, Bloem BR. A meta-analysis of six prospective studies of falling in Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1892-900. doi: 10.1002/mds.21598.

    PubMed 17588236
  • Wood BH, Bilclough JA, Bowron A, Walker RW. Incidence and prediction of falls in Parkinson's disease: a prospective multidisciplinary study. J Neurol Neurosurg Psychiatry. 2002 Jun;72(6):721-5. doi: 10.1136/jnnp.72.6.721.

    PubMed 12023412
  • Stolze H, Klebe S, Zechlin C, Baecker C, Friege L, Deuschl G. Falls in frequent neurological diseases--prevalence, risk factors and aetiology. J Neurol. 2004 Jan;251(1):79-84. doi: 10.1007/s00415-004-0276-8.

    PubMed 14999493
  • Koller WC, Glatt S, Vetere-Overfield B, Hassanein R. Falls and Parkinson's disease. Clin Neuropharmacol. 1989 Apr;12(2):98-105. doi: 10.1097/00002826-198904000-00003.

    PubMed 2720700
  • Gray P, Hildebrand K. Fall risk factors in Parkinson's disease. J Neurosci Nurs. 2000 Aug;32(4):222-8. doi: 10.1097/01376517-200008000-00006.

    PubMed 10994536
  • Bloem BR, Grimbergen YA, Cramer M, Willemsen M, Zwinderman AH. Prospective assessment of falls in Parkinson's disease. J Neurol. 2001 Nov;248(11):950-8. doi: 10.1007/s004150170047.

    PubMed 11757958
  • Paul SS, Canning CG, Sherrington C, Lord SR, Close JC, Fung VS. Three simple clinical tests to accurately predict falls in people with Parkinson's disease. Mov Disord. 2013 May;28(5):655-62. doi: 10.1002/mds.25404. Epub 2013 Feb 28.

    PubMed 23450694

Questions about this trial

What is this clinical trial studying?

A study testing Body Sensor Network in people with Parkinson Disease, run by RWTH Aachen University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to COVID-19 pandemic and new regulatory requirements). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Assessment with Wearable Movement Sensors (time frame: 5 days -12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04054856, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023; AzTrials last refreshed its copy on 1 Nov 2026.

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