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NCT05687773
The Effect of Immersion in Virtual Reality on Upper Limb Functionality in Subjects With Parkinson's Disease: Randomized Clinical Trial
Conditions: Parkinson Disease
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 30
Sponsor: Fernanda Cechetti
Location: Brazil
Summary
Introduction: Parkinson's Disease (PD) is characterized as a neurodegenerative disorder associated with the progressive loss of dopamine in the basal ganglia region, resulting in classic motor symptoms such as bradykinesia, rigidity, postural instability and tremor.
Such symptoms end up affecting the functionality of the upper limbs (ULM) in this population.
In recent years, therapy based on Virtual Reality (VR) has been gaining popularity, but studies in the area are still lacking.
Objective: To verify the benefits of immersive and non-immersive virtual reality in the functionality of the upper limbs in individuals with PD, and to identify possible differences between them.
Methodology: This is a randomized clinical trial, in which the evaluators will be separate from the experimental groups (single-blind).
Subjects with PD will be randomized into two groups: Immersive group (IVR), which will receive treatment with virtual reality games in an immersive environment through Leap Motion Controller (LMC) devices together with image projection on a Head-mounted -display (Oculus Quest) and the non-immersive group (RVnI) in which they will receive treatment with the CML on a flat screen.
Both treatments will focus on broad and fine upper limb tasks, in a protocol with 4 activities and duration of 27 minutes, twice a week, for eight weeks.
The two groups will be evaluated in three moments: before the intervention, immediately after 8 weeks and 60 days after the end of the interventions.
They will be analyzed in terms of ADLs, through the TEMPA test and part II of the unified assessment of PD (MDS-UPDRS II); motor assessment (part III) of the MDS-UPDRS and motor staging of PD (Hoehn & Yahr); manual dexterity through the Box and Block test and through the Nine Hole Peg Test; cognition by Montreal Cognitive Assessment (MoCA); quality of life through the PD questionnaire (PDQ-39); the usability of the system (SUS); and possible side effects (Simulator Sickness Questionnaire).
This study is expected to show that treatment with immersive VR has greater positive effects than non-immersive VR on the functionality of the upper limbs of individuals with PD.
Eligibility Criteria
Inclusion Criteria:Are diagnosed with Parkinson's disease;That they are classified between I III on the Hoehn & Yahr motor staging scale;Men who score greater than 21.1 seconds for the dominant limb and 22.3 seconds for the non-dominant limb for the nine-hole peg test.Women who scored greater than 19.9 seconds for the dominant limb and 21.4 seconds for the non-dominant limb for the nine-hole peg test.Exclusion Criteria:Have a brain pacemaker implant;Have recent injuries or limitations that make it impossible for the upper limbs to function;Do not perform/abstain from two visits out of the 16 proposed in the intervention protocol regardless of the group that will be allocated.
Source: ClinicalTrials.gov (NCT05687773). StuddyBuddy aggregates publicly available trial information.