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

Multiple Sclerosis Clinical Trial

— MEFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266444
• Other study ID #: URIS202001
• Status: Completed
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: September 29, 2021

Study information

• Verified date: September 2021
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Parkinson Disease
• Sclerosis

Intervention

Device:
• Exergaming in virtual environment
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.

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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