Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease (MEFA)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Parkinson Disease
• Intervention / Treatment: Device: Exergaming in virtual environment

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Rehabilitation Institute, Republic of Slovenia

Participation Criteria

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:

• 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.

Exclusion Criteria:

• any communicable disease;
• severe vision impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Level 4; 10Cubes game in virtual reality using very small 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.
ACTIVE_COMPARATOR: Level 3; 10Cubes game in virtual reality using very small 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.
ACTIVE_COMPARATOR: Level 2; 10Cubes game in virtual reality using large 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.
ACTIVE_COMPARATOR: Level 1; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Assessment at the end of each exergaming session; median across assessments will be taken as the outcome on each subscale

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Assessment at baseline and after two weeks

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia

Publications and helpful links

General 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.
• Cikajlo 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 6, 2020
• Primary Completion (ACTUAL): September 29, 2021
• Study Completion (ACTUAL): September 29, 2021

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (ACTUAL): February 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: virtual reality; motivation; neuropsychological tests; exergaming
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Multiple Sclerosis; Sclerosis; Parkinson Disease
• Other Study ID Numbers: URIS202001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No