The Effect of Immersion in Virtual Reality on Upper Limb Functionality in Subjects With Parkinson's Disease: Randomized Clinical Trial

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.

Conditions

• Parkinson Disease

Interventions

DEVICE

Leap Motion Controller on flat display

The LMC is a device with a Universal Serial Bus (USB) device capable of detecting the movement of hands and fingers. It is small in size and you need to connect the USB device to the computer and place your hands above the LMC. First, training will be carried out with the Leap Motion Controller instrument for 5 minutes, for a presentation and interaction with it, in the initial meeting. From the second meeting, the service protocol will be 16 sessions, this time being distributed as: first game lasting 7 minutes, second and third games lasting 6 minutes each and the last game lasting 8 minutes, totaling 27 minutes of intervention. Between games, about 2 minutes of rest was adopted. They were chosen through the website www.leapmotion.com¸ in order to relate them to the functional movements of the upper limbs in daily life tasks.

DEVICE

Leap Motion Controller in Head-Mounted Display

For the immersive group, the same equipment mentioned above Leap Motion Controller will be projected on the Head-Mounted Display model Oculus Quest 2 (Meta Platforms Inc.). The device has binocular displays with Fresnel lenses with a resolution of 1832 by 1920 pixels per eye. It is equipped with a Qualcomm Snapdragon XR2 processor with the refresh rate of 72hz - 120hz and 6GB of RAM. The equipment has a 90º field of view and approximately 500 grams of total weight. The treatment protocol and patient positioning will be the same as previously mentioned, except for the type of projection used. At the 2-minute rest interval between games, the HMD will be removed from the user to change the game in question, returning at the end of this period.

Sponsors & Collaborators

• Fernanda Cechetti

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2023-07-14

Completion

2023-09-14

Countries

• Brazil

Study Locations