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Completed

NCT Number: NCT04266444

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.

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Key information

Conditions

Parkinson Disease Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Movement Disorders Multiple Sclerosis Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exergaming in virtual environment

Device

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 outcomes

  1. Change in Box & Blocks Test from baseline

    Time frame: 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.

  2. Change in Frontal Assessment Battery (FAB) score from baseline

    Time frame: 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.

  3. Intrinsic Motivation Inventory (IMI) scores

    Time frame: 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 outcomes

  1. Change in Delis-Kaplan Executive Function System (D-KEFS) scores from baseline

    Time frame: Assessment at baseline and after two weeks

    Set of nine subtests of executive functions with complex computerised scoring; higher scores indicate better outcome.

  2. Change in Judgment of Line Orientation (JLO)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia

Other

Registry information

Official study title

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

Acronym: MEFA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2020
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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