Age Dependents Benefits of Virtual Reality Rehabilitation

NCT05922046 | Completed DMC

• 1 other identifier: ParkinsonAgeVR23
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

ntroduction: Parkinson\'s disease (PD) is characterized as a neurodegenerative disorder associated with 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 (MMS) in this population. In recent years, Virtual Reality (VR)-based therapy has been gaining popularity, but studies in the area are still lacking. Objective: To verify the benefits of virtual reality in individuals with PD above 65 years of age and in individuals below 65 years of age in the functionality of the upper limbs and to identify possible differences between them. Methodology: This is a randomized clinical trial, in which the evaluators will be separated into two experimental groups. Subjects with PD will be randomized into two groups: Group 65 years or over (GI1), and Group below 65 years of age (GI2). Both will receive treatment with virtual reality games in a non-immersive environment (flat screen) through the Leap Motion Controller (LMC) device. Both treatments will focus on large and fine upper limb tasks, in a protocol with 4 activities and duration of approximately 27 minutes, twice a week, for eight weeks. The two groups will be evaluated in three moments: before the intervention and immediately after 8 weeks. They will be analyzed manual dexterity through the Box and Block test and the Nine Hole Peg Test, Activities of Daily Living level through the TEMPA test and part II of the unified PD assessment (MDS-UPDRS II); motor assessment (part III) of the MDS-UPDRS ; cognition by Montreal Cognitive Assessment (MoCA); quality of life through the PD questionnaire (PDQ-39);. It is expected that this study will show that the treatment applied to the younger population presents better results when applied to the older population.

Conditions

Parkinson Disease

Keywords

Virtual Reality; Parkinson Disease; Upper Limb

Outcome Measures

Primary Outcomes (1)

• Box and Block Test

  For the application of the manual dexterity test, a wooden box measuring 53.7 cm is required, with a wooden partition that is higher than the edges of the box, separating it into two compartments of equal dimensions. The blocks are also made of wood and in the form of colored cubes (primary colors) measuring 2.5 cm on each side, totaling 150 units, divided equally by color. When starting the test, always with the dominant hand. The examinee will have 15 seconds of training. Then the transported blocks must return to the original compartment. The applicator must use a stopwatch to be able to interrupt the tasks after 1 minute. Repeat the test with the non-dominant hand. The test result is expressed by a score that indicates the number of blocks transported from one compartment to another per minute (blocks/minute)

  Pre-intervention and post-intervention (8 weeks of intervention).

Secondary Outcomes (7)

• UPDRS part II and III.

  Pre-intervention and post-intervention (8 weeks of intervention).

• Nine Hole Peg Test

  Pre-intervention and post-intervention (8 weeks of intervention).

• Montreal Cognitive Assessement

  Pre-intervention and post-intervention (8 weeks of intervention)

• TEMPA test (Test d'Évaluation des Membres Supérieurs de Personnes Agées)

  Time Frame: Pre and Post Immediate intervention

• Simulator sickness questionnaire

  up to 1 week

Study Arms (2)

Subjects with Parkinson's Disease over 65 years of age

EXPERIMENTAL

Individuals diagnosed with Parkinson's disease who are at least 65 years old on the date of initial assessment will be selected.

Device: Leap Motion Controller on flat display

Subjects with Parkinson's disease under 65 years

EXPERIMENTAL

Individuals diagnosed with Parkinson's disease aged between 18 and 64 years on the date of the initial assessment will be selected.

Device: Leap Motion Controller on flat 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.

Subjects with Parkinson's Disease over 65 years of age; Subjects with Parkinson's disease under 65 years

Eligibility Criteria

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

You may qualify if:

• Parkinson\'s disease diagnostic;
• Classified as I-III on the Hoehn \& Yahr motor staging scale;
• Are over 18 years old (above this, without age restriction).
• Residents in the city of Porto Alegre / RS.
• Have signed an informed consent form.
• To identify subjects with manual dexterity deficits, a cut-off score of 21.1 seconds for the dominant limb and 22.3 seconds for the non-dominant limb was used for male subjects, and 19.9 seconds for the dominant limb and 21.4 seconds for the non-dominant limb was used for female subjects on the Nine-Hole Peg Test (9HPT)

You may not qualify if:

• Do not show the understanding of the games on the first day of familiarization;
• Have a cerebral pacemaker implant;
• Have recent injuries or limitations that make the MMSS impossible.
• Do not perform / abstain from two appointments out of the 16 proposed in the intervention protocol, regardless of the group that will be allocated.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre

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

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 28, 2023
• Study Start: March 1, 2024
• Primary Completion: April 22, 2024
• Study Completion: August 8, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)