Clinical trial NCT04266444: Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease
Official title: Motivation, Neuropsychological Testing and Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Multiple Sclerosis
Keywords: exergaming
virtual reality
neuropsychological tests
motivation
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Box & Blocks Test from baseline
timeFrame: Assessment at baseline and after two weeks
measure: Change in Frontal Assessment Battery (FAB) score from baseline
timeFrame: Assessment at baseline and after two weeks
measure: Intrinsic Motivation Inventory (IMI) scores
timeFrame: Assessment at the end of each exergaming session; median across assessments will be taken as the outcome on each subscale
Secondary outcomes:
measure: Change in Delis-Kaplan Executive Function System (D-KEFS) scores from baseline
timeFrame: Assessment at baseline and after two weeks
measure: Change in Judgment of Line Orientation (JLO)
timeFrame: Assessment at baseline and after two weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Imre Cikajlo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.