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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Parkinson Disease, Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: Exergaming in virtual environment


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Level 4<br>10Cubes game in virtual reality using very small bouncing blocks | Device: Exergaming in virtual environment<br>* 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.<br>|
| Active Comparator: Level 3<br>10Cubes game in virtual reality using very small non-bouncing blocks | Device: Exergaming in virtual environment<br>* 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.<br>|
| Active Comparator: Level 2<br>10Cubes game in virtual reality using large bouncing blocks | Device: Exergaming in virtual environment<br>* 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.<br>|
| Active Comparator: Level 1<br>10Cubes game in virtual reality using large non-bouncing blocks | Device: Exergaming in virtual environment<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exergaming, virtual reality, neuropsychological tests, motivation