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Exergaming in Upper Extremities for Persons With Parkinson's Disease (PD_managerSI)

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ClinicalTrials.gov Identifier: NCT03175107
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
Jozef Stefan Institute
Information provided by (Responsible Party):
University Rehabilitation Institute, Republic of Slovenia

Tracking Information
First Submitted Date  ICMJE May 22, 2017
First Posted Date  ICMJE June 5, 2017
Last Update Posted Date April 24, 2018
Actual Study Start Date  ICMJE November 2, 2015
Actual Primary Completion Date December 23, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
Change in Box & Blocks Test from baseline [ Time Frame: Assessment at baseline and at five weeks ]
Standard clinical test to assesses unilateral gross manual dexterity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
  • Change in Nine Hole Peg Test from baseline [ Time Frame: Assessment at baseline and at five weeks ]
    Standard clinical test for measuring finger dexterity and other aspects of upper extremity function
  • Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline [ Time Frame: Assessment at baseline and at five weeks ]
    MDS-UPDRS is a comprehensive assessment designed to monitor the burden and extent of Parkinson's disease
  • Change in Jebsen Hand Function Test (JHFT) from baseline [ Time Frame: Assessment at baseline and at five weeks ]
    JHFT assesses a broad range of uni-manual hand functions required for activities of daily living
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exergaming in Upper Extremities for Persons With Parkinson's Disease
Official Title  ICMJE mHealth Platform for Parkinson's Disease Management: Exergaming in Upper Extremities for Persons With Parkinson's Disease
Brief Summary The purpose of the PD_manager project is to explore and develop innovative ecosystem management for people with Parkinson's disease. The research part contains expert analysis of diagnostic tests and decomposition of activity, accompanied by modern IT. The results of the analysis will be compared with the results of clinical trials that fall under the routine clinical pathways in monitoring a patient with Parkinson's disease. The primary motor symptoms, such as tremor, bradykinesia and impaired balance, and other symptoms, such as sleep disturbances, speech and cognitive perception, will be assessed by unobtrusive sensors (shoe insoles, bracelets) and sensors embedded in a mobile phone. The collected data will be analyzed using data mining methods and a platform for clinical decision support will be developed. This way, dependency of the patients on other persons will be reduced and the patients' quality of life improved. The patients will be motivated to follow the prescribed diet and take regular medication; the patients' activities will be monitored by occupational therapists and physiotherapists. A technical system will be designed as a computing platform in the open architecture cloud (FI-WARE), which will allow the use of commercially available sensors.
Detailed Description

The application of tasks in virtual reality and computer games for motoric exercise in patients with neurologic impairment is already quite widespread. It allows controlled workout and flexible gradation of difficulty of the task, which is essential for rehabilitation. Even in patients with Parkinson's disease, it allows for the gradual physiotherapy to improve range of mobility and improve fine motor skills of upper extremities. Within the project, existing games (Microsoft Xbox, Kinect) will be used and a special application for the Microsoft Kinect and Leap Motion systems will be developed, both for the movement of upper extremities as well as fine motor skills (plugs, 9 hole, labyrinth). Both systems will allow data storage, overview of the results, and the algorithm will also adapt the difficulty level of the tasks. This will allow creation of scenarios, as well as monitoring the gradual progress in rehabilitation. The study will begin with treatment in a hospital (URI-Soca), testing three platforms (Kinect, Leap Motion, plate). The most appropriate and most scalable solution will be further developed to the stage where it can be installed in the patient's home. The control of the system and data access will be performed remotely via the Internet and/or mobile phone. When the system is tested and evaluated at the patient's home, a user-friendly application will be developed for the patient to set the desired functions, for the therapist to set difficulty levels and provide instructions to the patient, and for the physician to examine the data and clinically evaluate the patient's condition.

The participants will test the application for up to 4 weeks and then report on the user experience. A standardized questionnaire (NRS 2002) will be used for this purpose. URI-Soca will recruit at least 7 patients, inpatients or outpatients for motor rehabilitation of upper extremities. The tasks will be carried out at the occupational therapy and physiotherapy units of URI-Soca for up to 4 weeks, 3 times a week. At the same time, expert analysis (neurologist, physiotherapist, occupational therapist, engineer) of the measured data (kinematics, the results achieved) will be performed and clinical tests (Unified Parkinson's Disease Rating Scale - UPDRS, Jebsen Tailor Functional Test and PD Questionnaire 39) will be carried out before and after the exercise program. At the same time, the system will be adapted for home use (by at least 1 patient), and then a study will be conducted with other patients. These participants will receive the system for home use for up to 60 days. The data will be accessed remotely over the Internet, so the objective evaluation can be carried out promptly. The clinical test will be conducted before exercise and after exercise, i.e., at the beginning and at the end of the observation period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Device: Exergaming
Study Arms  ICMJE Experimental: PD_patients
Patients with Parkinson disease or Parkinsonism (characteristic symptoms such as rigidity, extrapyramidal symptoms), with functional disorders in upper extremities and minor problems at daily activities, with the level 2-3 in the Hoehn and Yahr Scale. They will perform exergaming at home for up to 4 weeks.
Intervention: Device: Exergaming
Publications * Cikajlo I, Hukić A, Zajc D. Exergaming as Part of the Telerehabilitation Can Be Adequate to the Outpatient Training: Preliminary Findings of a Non-randomized Pilot Study in Parkinson's Disease. Front Neurol. 2021 Mar 16;12:625225. doi: 10.3389/fneur.2021.625225. eCollection 2021.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2017)
47
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Parkinson disease or Parkinsonism (characteristic symptoms such as rigidity, extrapyramidal symptoms), with functional disorders in upper extremities and minor problems at daily activities;
  • Level 2-3 in the Hoehn and Yahr Scale.

Exclusion Criteria:

  • Any communicable disease;
  • Severe vision impairment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03175107
Other Study ID Numbers  ICMJE URIS201702
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Rehabilitation Institute, Republic of Slovenia
Study Sponsor  ICMJE University Rehabilitation Institute, Republic of Slovenia
Collaborators  ICMJE Jozef Stefan Institute
Investigators  ICMJE
Principal Investigator: Imre Cikajlo, PhD University Rehabilitation Institute, Rehabilitation of Slovenia
PRS Account University Rehabilitation Institute, Republic of Slovenia
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP