Parkinson Disease Clinical Trial
— PD_managerSIOfficial title:
mHealth Platform for Parkinson's Disease Management: Exergaming in Upper Extremities for Persons With Parkinson's Disease
Verified date | April 2018 |
Source | University Rehabilitation Institute, Republic of Slovenia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 23, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Slovenia | University Rehabilitation Institute, Republic of Slovenia | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Rehabilitation Institute, Republic of Slovenia | Jozef Stefan Institute |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Box & Blocks Test from baseline | Standard clinical test to assesses unilateral gross manual dexterity | Assessment at baseline and at five weeks | |
Secondary | Change in Nine Hole Peg Test from baseline | Standard clinical test for measuring finger dexterity and other aspects of upper extremity function | Assessment at baseline and at five weeks | |
Secondary | Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline | MDS-UPDRS is a comprehensive assessment designed to monitor the burden and extent of Parkinson's disease | Assessment at baseline and at five weeks | |
Secondary | Change in Jebsen Hand Function Test (JHFT) from baseline | JHFT assesses a broad range of uni-manual hand functions required for activities of daily living | Assessment at baseline and at five weeks |
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