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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03175107
Date of registration: 22/05/2017
Prospective Registration: No
Primary sponsor: University Rehabilitation Institute, Republic of Slovenia
Public title: Exergaming in Upper Extremities for Persons With Parkinson's Disease PD_managerSI
Scientific title: mHealth Platform for Parkinson's Disease Management: Exergaming in Upper Extremities for Persons With Parkinson's Disease
Date of first enrolment: November 2, 2015
Target sample size: 47
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03175107
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Slovenia
Contacts
Name:     Imre Cikajlo, PhD
Address: 
Telephone:
Email:
Affiliation:  University Rehabilitation Institute, Rehabilitation of Slovenia
Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson Disease
Intervention(s)
Device: Exergaming
Primary Outcome(s)
Change in Box & Blocks Test from baseline [Time Frame: Assessment at baseline and at five weeks]
Secondary Outcome(s)
Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline [Time Frame: Assessment at baseline and at five weeks]
Change in Nine Hole Peg Test from baseline [Time Frame: Assessment at baseline and at five weeks]
Change in Jebsen Hand Function Test (JHFT) from baseline [Time Frame: Assessment at baseline and at five weeks]
Secondary ID(s)
URIS201702
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Jozef Stefan Institute
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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