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

NCT04054856 | Terminated

• 1 other identifier: 17-041
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (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.

  5 days -12 weeks

Study Arms (2)

Patients with Morbus Parkinson

OTHER

Device: Body Sensor Network

Healthy Subjects

OTHER

Device: Body Sensor Network

Interventions

Body Sensor Network DEVICE

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; Patients with Morbus Parkinson

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• age of majority
• written declaration of consent
• persons who are legally competent and mentally able to follow the instructions of the study staff

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• RWTH Aachen University: lead
• Medical Information Technology (MedIT), RWTH Aachen University: collaborator

Study Sites (1)

Department of Neurology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (8)

• 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.

  PMID: 17667192 BACKGROUND

• 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.

  PMID: 17588236 BACKGROUND

• 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.

  PMID: 12023412 BACKGROUND

• 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.

  PMID: 14999493 BACKGROUND

• 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.

  PMID: 2720700 BACKGROUND

• 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.

  PMID: 10994536 BACKGROUND

• 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.

  PMID: 11757958 BACKGROUND

• 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.

  PMID: 23450694 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Kathrin Reetz, Prof. Dr.

  Departmet of Neurology, University Clinic Aachen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: August 13, 2019
• Study Start: December 16, 2019
• Primary Completion: April 20, 2022
• Study Completion: March 6, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)