3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease (10Cubes)
December 17, 2018 updated by: University Rehabilitation Institute, Republic of Slovenia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ljubljana, Slovenia, 1000
- University Rehabilitation Institute, Republic of Slovenia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
The "10 cubes" task will be performed in virtual environment - either in 2D on a laptop computer or in 3D using 3D goggles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session
|
|
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
|
DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2018
Primary Completion (Actual)
December 16, 2018
Study Completion (Actual)
December 16, 2018
Study Registration Dates
First Submitted
April 23, 2018
First Submitted That Met QC Criteria
April 23, 2018
First Posted (Actual)
May 4, 2018
Study Record Updates
Last Update Posted (Actual)
December 19, 2018
Last Update Submitted That Met QC Criteria
December 17, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URIS201801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.