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

Not Applicable

Completed

• Conditions: Parkinson Disease; Multiple Sclerosis
• Interventions: Device: Exergaming in virtual environment

• Registration Number: NCT04266444
• Lead Sponsor: University Rehabilitation Institute, Republic of Slovenia

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.

Study Timeline

• Study Start: 2020-02-06
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-12
• Status Verified: 2021-09
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Level 1	Exergaming in virtual environment	10Cubes game in virtual reality using large non-bouncing blocks
Level 2	Exergaming in virtual environment	10Cubes game in virtual reality using large bouncing blocks
Level 4	Exergaming in virtual environment	10Cubes game in virtual reality using very small bouncing blocks
Level 3	Exergaming in virtual environment	10Cubes game in virtual reality using very small non-bouncing blocks

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Rehabilitation Institute, Republic of Slovenia; 🇸🇮 Ljubljana, Slovenia