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

Sponsor

University Rehabilitation Institute, Republic of Slovenia (Other)

Overall Status

Completed

CT.gov ID

NCT04266444

Collaborator

(none)

108

Enrollment

Location

Arms

19.7

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Multiple Sclerosis	Device: Exergaming in virtual environment	N/A

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

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Motivation, Neuropsychological Testing and Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease

Actual Study Start Date :

Feb 6, 2020

Actual Primary Completion Date :

Sep 29, 2021

Actual Study Completion Date :

Sep 29, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change in Box & Blocks Test from baseline [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 [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 [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.

Secondary Outcome Measures

Change in Delis-Kaplan Executive Function System (D-KEFS) scores from baseline [Assessment at baseline and after two weeks]
Set of nine subtests of executive functions with complex computerised scoring; higher scores indicate better outcome.
Change in Judgment of Line Orientation (JLO) [Assessment at baseline and after two weeks]
Standardized test of visuospatial skills; the minimum possible score is 0, the maximum is 30; higher score indicates better outcome.