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

Primary Purpose

Parkinson Disease, Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Exergaming in virtual environment
Sponsored by
University Rehabilitation Institute, Republic of Slovenia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring exergaming, virtual reality, neuropsychological tests, motivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Rehabilitation Institute, Republic of Slovenia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Level 4

Level 3

Level 2

Level 1

Arm Description

10Cubes game in virtual reality using very small bouncing blocks

10Cubes game in virtual reality using very small non-bouncing blocks

10Cubes game in virtual reality using large bouncing blocks

10Cubes game in virtual reality using large non-bouncing blocks

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 6, 2020
Last Updated
September 29, 2021
Sponsor
University Rehabilitation Institute, Republic of Slovenia
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1. Study Identification

Unique Protocol Identification Number
NCT04266444
Brief Title
Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease
Acronym
MEFA
Official Title
Motivation, Neuropsychological Testing and Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
September 29, 2021 (Actual)
Study Completion Date
September 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Rehabilitation Institute, Republic of Slovenia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Multiple Sclerosis
Keywords
exergaming, virtual reality, neuropsychological tests, motivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Level 4
Arm Type
Active Comparator
Arm Description
10Cubes game in virtual reality using very small bouncing blocks
Arm Title
Level 3
Arm Type
Active Comparator
Arm Description
10Cubes game in virtual reality using very small non-bouncing blocks
Arm Title
Level 2
Arm Type
Active Comparator
Arm Description
10Cubes game in virtual reality using large bouncing blocks
Arm Title
Level 1
Arm Type
Active Comparator
Arm Description
10Cubes game in virtual reality using large non-bouncing blocks
Intervention Type
Device
Intervention Name(s)
Exergaming in virtual environment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Box & Blocks Test from baseline
Description
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
Title
Change in Frontal Assessment Battery (FAB) score from baseline
Description
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
Title
Intrinsic Motivation Inventory (IMI) scores
Description
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
Secondary Outcome Measure Information:
Title
Change in Delis-Kaplan Executive Function System (D-KEFS) scores from baseline
Description
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
Title
Change in Judgment of Line Orientation (JLO)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imre Cikajlo, PhD
Organizational Affiliation
University Rehabilitation Institute, Republic of Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Rehabilitation Institute, Republic of Slovenia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31623622
Citation
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.
Results Reference
background
PubMed Identifier
36371421
Citation
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.
Results Reference
derived

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

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