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

NCT05687773 | Unknown DMC

• 1 other identifier: ParkinsonVR22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Virtual Reality; Parkinson Disease; Upper Limb

Outcome Measures

Primary Outcomes (3)

• TEMPA test

  It is an instrument used to assess the degree of disability of the upper limbs. It presents a manual on how to manage it, the necessary measures to make the box and where to place each specific material for the tasks . The materials needed for administering the test are as follows: 100 grams coffee pot, 1000 milliliters water jug, coffee spoon, cup, water glass, medicine pot and 10 placebo capsules, white envelopes, stamp, pencil , card game, coins, small glass jar, small objects, piece of non-slip material and sheets for recording scores.Tasks are evaluated in different ways, first by the speed of execution, and the time must be timed. Then, the functional rating, which refers to the autonomy to perform each task, must be evaluated.

  Pre-intervention (baseline).

• TEMPA test

  It is an instrument used to assess the degree of disability of the upper limbs. It presents a manual on how to manage it, the necessary measures to make the box and where to place each specific material for the tasks . The materials needed for administering the test are as follows: 100 grams coffee pot, 1000 milliliters water jug, coffee spoon, cup, water glass, medicine pot and 10 placebo capsules, white envelopes, stamp, pencil , card game, coins, small glass jar, small objects, piece of non-slip material and sheets for recording scores.Tasks are evaluated in different ways, first by the speed of execution, and the time must be timed. Then, the functional rating, which refers to the autonomy to perform each task, must be evaluated.

  Post-intervention (8 weeks of intervention).

• TEMPA test

  It is an instrument used to assess the degree of disability of the upper limbs. It presents a manual on how to manage it, the necessary measures to make the box and where to place each specific material for the tasks . The materials needed for administering the test are as follows: 100 grams coffee pot, 1000 milliliters water jug, coffee spoon, cup, water glass, medicine pot and 10 placebo capsules, white envelopes, stamp, pencil , card game, coins, small glass jar, small objects, piece of non-slip material and sheets for recording scores.Tasks are evaluated in different ways, first by the speed of execution, and the time must be timed. Then, the functional rating, which refers to the autonomy to perform each task, must be evaluated.

  Follow-up (After 2 months of completion of the intervention).

Secondary Outcomes (6)

• MDS-UPDRS

  Pre-intervention and post-intervention (8 weeks of intervention). And after 8 weeks (Follow-up).

• Simulator Sickness Questionnaire

  After each intervention session (16 sessions for 8 weeks in total)

• Box and Block Test

  Pre-intervention and post-intervention (8 weeks of intervention). And after 8 weeks (Follow-up).

• Nine Hole Peg Test

  Pre-intervention and post-intervention (8 weeks of intervention). And after 8 weeks (Follow-up).

• Montreal Cognitive Assessement

  Pre-intervention and post-intervention (8 weeks of intervention). And after 8 weeks (Follow-up).

Study Arms (2)

Leap Motion Controller on Flat display - Non-Immersive Group

EXPERIMENTAL

Device: Leap Motion Controller on flat display

Leap Motion Controller on Head-Mounted Display - Immersive Group

EXPERIMENTAL

Device: Leap Motion Controller in Head-Mounted Display

Interventions

Leap Motion Controller on flat display DEVICE

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.

Leap Motion Controller on Flat display - Non-Immersive Group

Leap Motion Controller in Head-Mounted Display DEVICE

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.

Leap Motion Controller on Head-Mounted Display - Immersive Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fernanda Cechetti: lead

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Smart Glasses

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: January 18, 2023
• Study Start: September 1, 2021
• Primary Completion: July 14, 2023
• Study Completion: September 14, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

BR (1)