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

NCT04266444 | Completed

• 1 other identifier: URIS202001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Multiple Sclerosis

Keywords

exergaming; virtual reality; neuropsychological tests; motivation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

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

  Assessment at baseline and after two weeks

• Change in Judgment of Line Orientation (JLO)

  Assessment at baseline and after two weeks

Study Arms (4)

Level 4

ACTIVE COMPARATOR

10Cubes game in virtual reality using very small bouncing blocks

Device: Exergaming in virtual environment

Level 3

ACTIVE COMPARATOR

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

Device: Exergaming in virtual environment

Level 2

ACTIVE COMPARATOR

10Cubes game in virtual reality using large bouncing blocks

Device: Exergaming in virtual environment

Level 1

ACTIVE COMPARATOR

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

Device: Exergaming in virtual environment

Interventions

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.

Level 1; Level 2; Level 3; Level 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• any communicable disease;
• severe vision impairment.

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

Related Publications (2)

• 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.

  PMID: 31623622 BACKGROUND

• 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.

  PMID: 36371421 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Imre Cikajlo, PhD

  University Rehabilitation Institute, Republic of Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 12, 2020
• Study Start: February 6, 2020
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)