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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Exergaming||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||mHealth Platform for Parkinson's Disease Management: Exergaming in Upper Extremities for Persons With Parkinson's Disease|
|Actual Study Start Date :||November 2, 2015|
|Actual Primary Completion Date :||December 23, 2016|
|Actual Study Completion Date :||December 31, 2017|
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.
- 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
- 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
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): NCT03175107
|University Rehabilitation Institute, Republic of Slovenia|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Imre Cikajlo, PhD||University Rehabilitation Institute, Rehabilitation of Slovenia|