Parkinson Disease10CubesNCT03515746
3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease
A study testing Exergaming in virtual environment in people with Parkinson Disease, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Exergaming in virtual environment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 11 May 2018to 16 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease diagnosis
- minor problems with daily activities and upper extremities
- Hoehn and Yahr Scale level 2-3
Who cannot join
- insufficient cognitive and motor abilities to carry out the exergaming task
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Exergaming in virtual environment
- Keywords
- exergaming, physiotherapy, upper extremities, telerehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergaming in virtual environmentDevice
The "10 cubes" task will be performed in virtual environment - either in 2D on a laptop computer or in 3D using 3D goggles
| Study group | Role | What they receive |
|---|---|---|
| Exergaming2D | Active comparator | 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. Receives: Device: Exergaming in virtual environment |
| Exergaming3D | Active comparator | 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. Receives: Device: Exergaming in virtual environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
UDPRS III Motor
Unified Parkinson's Disease Rating Scale Motor Function Part - difference score
Measured: DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session
BBT
Box \& Blocks Test - difference score
Measured: DIfference between the two assessments - a day or two before the first training sessions and immediately after the last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start11 May 2018
- Primary completion16 Dec 2018
- Study completion16 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, Slovenian Research Agency
- Responsible party
- Sponsor
- Investigators
- Imre Cikajlo, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515746
- Sponsor's protocol ID
- URIS201801
- Acronym
- 10Cubes
- Status last verified
- Dec 2018
- First submitted
- 23 Apr 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31623622
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03515746
- Acronym / sponsor ID
- 10Cubes / URIS201801
- Conditions
- Parkinson Disease
- Keywords
- exergaming, physiotherapy, upper extremities, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Collaborators
- European Regional Development Fund, Slovenian Research Agency
- Study start
- 11 May 2018 (actual)
- Primary completion
- 16 Dec 2018 (actual)
- Study completion
- 16 Dec 2018 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming2D | Active comparator | Device: Exergaming in virtual environmentThe 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. |
| Exergaming3D | Active comparator | Device: Exergaming in virtual environmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease diagnosis
- minor problems with daily activities and upper extremities
- Hoehn and Yahr Scale level 2-3
Key exclusion criteria (1 listed)
- insufficient cognitive and motor abilities to carry out the exergaming task
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergaming in virtual environmentThe "10 cubes" task will be performed in virtual environment - either in 2D on a laptop computer or in 3D using 3D goggles | Device | Exergaming2D, Exergaming3D |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Derived from this study: PubMed 31623622Cikajlo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imre Cikajlo, PhD principal investigator
University Rehabilitation Institute, Republic of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming in virtual environment in people with Parkinson Disease, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.