3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease (10Cubes)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Exergaming in virtual environment
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring exergaming, physiotherapy, upper extremities, telerehabilitation
Eligibility 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
Sites / Locations
- University Rehabilitation Institute, Republic of Slovenia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Exergaming2D
Exergaming3D
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
UDPRS III Motor
Unified Parkinson's Disease Rating Scale Motor Function Part - difference score
BBT
Box & Blocks Test - difference score
Secondary Outcome Measures
Full Information
NCT ID
NCT03515746
First Posted
April 23, 2018
Last Updated
December 17, 2018
Sponsor
University Rehabilitation Institute, Republic of Slovenia
Collaborators
European Regional Development Fund, Slovenian Research Agency
1. Study Identification
Unique Protocol Identification Number
NCT03515746
Brief Title
3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease
Acronym
10Cubes
Official Title
3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
December 16, 2018 (Actual)
Study Completion Date
December 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Rehabilitation Institute, Republic of Slovenia
Collaborators
European Regional Development Fund, Slovenian Research Agency
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
exergaming, physiotherapy, upper extremities, telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exergaming2D
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exergaming3D
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Exergaming in virtual environment
Intervention Description
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 Measure Information:
Title
UDPRS III Motor
Description
Unified Parkinson's Disease Rating Scale Motor Function Part - difference score
Time Frame
DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session
Title
BBT
Description
Box & Blocks Test - difference score
Time Frame
DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imre Cikajlo, PhD
Organizational Affiliation
University Rehabilitation Institute, Republic of Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Rehabilitation Institute, Republic of Slovenia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31623622
Citation
Cikajlo I, Peterlin Potisk K. Advantages of using 3D virtual reality based training in persons with Parkinson's disease: a parallel study. J Neuroeng Rehabil. 2019 Oct 17;16(1):119. doi: 10.1186/s12984-019-0601-1.
Results Reference
derived
Learn more about this trial
3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease
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