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3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease (10Cubes)

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ClinicalTrials.gov Identifier: NCT03515746
Recruitment Status : Completed
First Posted : May 4, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborators:
European Regional Development Fund
Slovenian Research Agency
Information provided by (Responsible Party):
University Rehabilitation Institute, Republic of Slovenia

Brief Summary:
A pilot study with the "10cubes" for small and precise movements and training in the virtual environment will be carried out. We will recruit at least 20 persons with Parkinson's disease to participate in the study. Such activities can increase participation, slow down the progress of the disease and contribute to the functional improvements of the hand that lead to the increased quality of life. The movement of the hand will be assessed with a small 3D camera, also suitable for the estimation of kinematic parameters. Participants will be randomized into 2 groups; one group using an LCD screen and the other using 3D goggles (Oculus Rift CV1) enabling them to carry out the task in virtual environment. Both groups will take 10 training sessions within 2 weeks. Their task will be collecting 10 virtual cubes one-by-one and putting them in the virtual treasure box. Clinical tests (Box and Blocks Test and motor part of the UPDRS) will be carried out in the clinical settings prior and after the training sessions. We hypothesise that the different feedback equipment may provide different results.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Exergaming in virtual environment Not Applicable

Detailed Description:
The participants will practise grab and grasp in virtual environment (VE), either on a laptop computer or using 3D goggles. They will sit in a comfortable chair, with a small camera tracking the hand and finger movements of their affected (dominant, in case of both hands affected) hand. The participant will grab any of the virtual cubes lying around the VE and put it in the treasure box. When the cube falls into the treasure box it disappears and the participant scores, one by one until the 10th cube or 120s of time elapse. The cubes will be randomly spread in the VE and will all have the same virtual size, weight and bouncing factor, but different colour. If the participant is left-handed, the treasure box will be mirrored to the right side. If the cube is pushed into the floor, it disappears without a score and is lost. Each participant will take 10 consecutive training sessions in 2 weeks, each session lasting for 30min. Within a session, the participant will take 5 trials, with breaks of 1-2 min between them.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease
Actual Study Start Date : May 11, 2018
Actual Primary Completion Date : December 16, 2018
Actual Study Completion Date : December 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exergaming2D
The participants will practise grab and grasp through exergaming in virtual environment (VE) on a laptop computer. During the task, they will sit in a comfortable chair in front of the screen.
Device: Exergaming in virtual environment
The "10 cubes" task will be performed in virtual environment - either in 2D on a laptop computer or in 3D using 3D goggles

Active Comparator: Exergaming3D
The participants will practise grab and grasp through exergaming in virtual environment (VE) in 3D VE using Oculus Rift CV1 3D goggles. During the task, they will sit in a comfortable chair with head-mounted 3D display.
Device: Exergaming in virtual environment
The "10 cubes" task will be performed in virtual environment - either in 2D on a laptop computer or in 3D using 3D goggles




Primary Outcome Measures :
  1. UDPRS III Motor [ Time Frame: DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session ]
    Unified Parkinson's Disease Rating Scale Motor Function Part - difference score

  2. BBT [ Time Frame: DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session ]
    Box & Blocks Test - difference score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's disease diagnosis
  • minor problems with daily activities and upper extremities
  • Hoehn and Yahr Scale level 2-3

Exclusion Criteria:

  • insufficient cognitive and motor abilities to carry out the exergaming task

Information from the National Library of Medicine

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): NCT03515746


Locations
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Slovenia
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Rehabilitation Institute, Republic of Slovenia
European Regional Development Fund
Slovenian Research Agency
Investigators
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Principal Investigator: Imre Cikajlo, PhD University Rehabilitation Institute, Republic of Slovenia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Rehabilitation Institute, Republic of Slovenia
ClinicalTrials.gov Identifier: NCT03515746     History of Changes
Other Study ID Numbers: URIS201801
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Rehabilitation Institute, Republic of Slovenia:
exergaming
physiotherapy
upper extremities
telerehabilitation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases