Parkinson DiseaseMEFANCT04266444
Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease
A study testing Exergaming in virtual environment in people with Parkinson Disease and Multiple Sclerosis, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial summary
The aim of the study is to optimise the hand dexterity exercising program in virtual reality (VR) for patients with multiple sclerosis and Parkinson's disease. Little research has been published on this topic, but the preliminary results are promising. Different levels of difficulty of a VR game will be tested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Multiple Sclerosis
- 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
- 108 participants
- Where
- 1 siteSlovenia
- Study dates
- 6 Feb 2020to 29 Sep 2021
- 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
- diagnose of Parkinson's disease or multiple sclerosis;
- Mini Mental State Examination score above 24;
- preserved upper limb function;
- for Parkinson's disease patients Hoehn and Yahr scale score between 2 and 3.
Who cannot join
- any communicable disease;
- severe vision impairment.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
Official title: Motivation, Neuropsychological Testing and Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease
The aim of the study is to optimise the hand dexterity exercising program in virtual reality (VR) for patients with multiple sclerosis and Parkinson's disease. Little research has been published on this topic, but the preliminary results are promising. Different levels of difficulty of a VR game will be tested. The patients will be assessed using neuropsychological tests of executive functions, visuospatial abilities, mental speed, flexibility and motor speed. Functional ability, coordination and cognitive abilities will also be assessed.
Read the detailed description
Each patient meeting the inclusion criteria will be randomised to one of the four groups (i.e., 10cubes game difficulty level). The patients will perform five exergaming sessions, each session lasting for 1 hour, on five consecutive working days within the period of two weeks. The 10cubes task requires that all 10 cubes are moved within 2 minutes. Each patient will perform the task 5 times in succession with 1-2 minute breaks. The patients will be assessed using the Box \& Blocks Test, Frontal Assessment Battery (FAB), Delis-Kaplan Executive Function System (D-KEFS) and Judgment of Line Orientation (JLO) before the first session and after the last session. In addition, the patients will fill in the Intrinsic Motivation Inventory (IMI) after each session. Based on statistical sample size calculations, the study plan is to include 80 patients with Parkinson's disease and 12 patients with multiple sclerosis randomising them separately, so that the groups will be balanced in terms of size and diagnosis.
- Conditions
- Parkinson Disease, Multiple Sclerosis
- Being tested
- Exergaming in virtual environment
- Keywords
- exergaming, virtual reality, neuropsychological tests, motivation
- Medical subject headings
- Parkinson Disease, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergaming in virtual environmentDevice
The 10Cubes game (by I. Cikajlo) will be used. In the game, the motion of the hand, wrist and fingers is tracked by an infra-red camera (by LeapMotion, Inc.) and hand motion is reflected in the virtual environment. The software will run on a powerful computer with a 19" display. Each group will have the game set to a different level of difficulty.
| Study group | Role | What they receive |
|---|---|---|
| Level 4 | Active comparator | 10Cubes game in virtual reality using very small bouncing blocks Receives: Device: Exergaming in virtual environment |
| Level 3 | Active comparator | 10Cubes game in virtual reality using very small non-bouncing blocks Receives: Device: Exergaming in virtual environment |
| Level 2 | Active comparator | 10Cubes game in virtual reality using large bouncing blocks Receives: Device: Exergaming in virtual environment |
| Level 1 | Active comparator | 10Cubes game in virtual reality using large non-bouncing blocks Receives: Device: Exergaming in virtual environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Box & Blocks Test from baseline
Standard clinical test to assesses unilateral gross manual dexterity; the minimum possible score is 0, the maximum is 150; higher score indicates better outcome.
Measured: Assessment at baseline and after two weeks
Change in Frontal Assessment Battery (FAB) score from baseline
Brief neuropsychological test battery to assess executive functions; the minimum possible score is 0, the maximum is 18; higher score indicates better outcome.
Measured: Assessment at baseline and after two weeks
Intrinsic Motivation Inventory (IMI) scores
The IMI is a multidimensional measurement instrument for assessing subjective experience of a target activity. The 22-item version that consists of four subscales will be used (scores range from 7 to 49 for one scale and from 5 to 35 for three scales); higher scores indicate better outcome.
Measured: Assessment at the end of each exergaming session; median across assessments will be taken as the outcome on each subscale
Secondary outcomes (2)
Change in Delis-Kaplan Executive Function System (D-KEFS) scores from baseline
Set of nine subtests of executive functions with complex computerised scoring; higher scores indicate better outcome.
Measured: Assessment at baseline and after two weeks
Change in Judgment of Line Orientation (JLO)
Standardized test of visuospatial skills; the minimum possible score is 0, the maximum is 30; higher score indicates better outcome.
Measured: Assessment at baseline and after two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start6 Feb 2020
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imre Cikajlo, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266444
- Sponsor's protocol ID
- URIS202001
- Acronym
- MEFA
- Status last verified
- Sep 2021
- First submitted
- 6 Feb 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31623622Cikajlo I, Hukic A, Udovcic Pertot A. The size and behavior of virtual objects have influence on functional exercise and motivation of persons with multiple sclerosis: a randomized study. Sci Rep. 2022 Nov 12;12(1):19375. doi: 10.1038/s41598-022-24046-3.
PubMed 36371421
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivation, Neuropsychological Testing and Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04266444
- Acronym / sponsor ID
- MEFA / URIS202001
- Conditions
- Parkinson Disease, Multiple Sclerosis
- Keywords
- exergaming, virtual reality, neuropsychological tests, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 12 Feb 2020 (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.
The aim of the study is to optimise the hand dexterity exercising program in virtual reality (VR) for patients with multiple sclerosis and Parkinson's disease. Little research has been published on this topic, but the preliminary results are promising. Different levels of difficulty of a VR game will be tested. The patients will be assessed using neuropsychological tests of executive functions, visuospatial abilities, mental speed, flexibility and motor speed. Functional ability, coordination and cognitive abilities will also be assessed.
Detailed description
Each patient meeting the inclusion criteria will be randomised to one of the four groups (i.e., 10cubes game difficulty level). The patients will perform five exergaming sessions, each session lasting for 1 hour, on five consecutive working days within the period of two weeks. The 10cubes task requires that all 10 cubes are moved within 2 minutes. Each patient will perform the task 5 times in succession with 1-2 minute breaks. The patients will be assessed using the Box \& Blocks Test, Frontal Assessment Battery (FAB), Delis-Kaplan Executive Function System (D-KEFS) and Judgment of Line Orientation (JLO) before the first session and after the last session. In addition, the patients will fill in the Intrinsic Motivation Inventory (IMI) after each session. Based on statistical sample size calculations, the study plan is to include 80 patients with Parkinson's disease and 12 patients with multiple sclerosis randomising them separately, so that the groups will be balanced in terms of size and diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Level 4 | Active comparator | Device: Exergaming in virtual environment10Cubes game in virtual reality using very small bouncing blocks |
| Level 3 | Active comparator | Device: Exergaming in virtual environment10Cubes game in virtual reality using very small non-bouncing blocks |
| Level 2 | Active comparator | Device: Exergaming in virtual environment10Cubes game in virtual reality using large bouncing blocks |
| Level 1 | Active comparator | Device: Exergaming in virtual environment10Cubes game in virtual reality using large non-bouncing blocks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnose of Parkinson's disease or multiple sclerosis;
- Mini Mental State Examination score above 24;
- preserved upper limb function;
- for Parkinson's disease patients Hoehn and Yahr scale score between 2 and 3.
Key exclusion criteria (2 listed)
- any communicable disease;
- severe vision impairment.
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 10Cubes game (by I. Cikajlo) will be used. In the game, the motion of the hand, wrist and fingers is tracked by an infra-red camera (by LeapMotion, Inc.) and hand motion is reflected in the virtual environment. The software will run on a powerful computer with a 19" display. Each group will have the game set to a different level of difficulty. | Device | Level 1, Level 2, Level 3, Level 4 |
Primary outcome
Change in Box & Blocks Test from baseline
Time frame: Assessment at baseline and after two weeks
Standard clinical test to assesses unilateral gross manual dexterity; the minimum possible score is 0, the maximum is 150; higher score indicates better outcome.
Change in Frontal Assessment Battery (FAB) score from baseline
Time frame: Assessment at baseline and after two weeks
Brief neuropsychological test battery to assess executive functions; the minimum possible score is 0, the maximum is 18; higher score indicates better outcome.
Intrinsic Motivation Inventory (IMI) scores
Time frame: Assessment at the end of each exergaming session; median across assessments will be taken as the outcome on each subscale
The IMI is a multidimensional measurement instrument for assessing subjective experience of a target activity. The 22-item version that consists of four subscales will be used (scores range from 7 to 49 for one scale and from 5 to 35 for three scales); higher scores indicate better outcome.
2 secondary outcomes
Change in Delis-Kaplan Executive Function System (D-KEFS) scores from baseline
Time frame: Assessment at baseline and after two weeks
Change in Judgment of Line Orientation (JLO)
Time frame: Assessment at baseline and after two weeks
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 30 Sep 2021.
- Background: 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.
- Derived from this study: PubMed 36371421Cikajlo I, Hukic A, Udovcic Pertot A. The size and behavior of virtual objects have influence on functional exercise and motivation of persons with multiple sclerosis: a randomized study. Sci Rep. 2022 Nov 12;12(1):19375. doi: 10.1038/s41598-022-24046-3.
- Individual participant dataSharing planned: No
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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 and Multiple Sclerosis, 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 4 inclusion and 2 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 30 Sep 2021. 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?
Change in Box & Blocks Test from baseline (time frame: Assessment at baseline and after two weeks). The study lists 3 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 NCT04266444, which also lists 2 linked publications.
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 30 Sep 2021.