An interventional study of Exergaming in virtual environment in Parkinson Disease and Multiple Sclerosis, sponsored by University Rehabilitation Institute, Republic of Slovenia. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by University Rehabilitation Institute, Republic of Slovenia · Not applicable, Interventional, and Treatment
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 108 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Rehabilitation Institute, Republic of Slovenia is the lead sponsor of 21 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
10Cubes game in virtual reality using very small bouncing blocks
Device: Exergaming in virtual environment
10Cubes game in virtual reality using very small non-bouncing blocks
Device: Exergaming in virtual environment
10Cubes game in virtual reality using large bouncing blocks
Device: Exergaming in virtual environment
10Cubes game in virtual reality using large non-bouncing blocks
Device: Exergaming in virtual environment
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Assessment at the end of each exergaming session; median across assessments will be taken as the outcome on each subscale
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.
Time frame: 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.
Time frame: Assessment at baseline and after two weeks
Plan to share: No
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University Rehabilitation Institute, Republic of Slovenia