Usability Study of a Neuropsychological Intervention Program Based on Virtual Reality in Adults With Parkinson's Disease

May 31, 2022 updated by: Corporación de Rehabilitación Club de Leones Cruz del Sur

Nowadays, several strategies for treating neuropsychologic function loss in Parkinson disease (PD) have been proposed, such as physical activity performance and developing games to exercise the mind. However, few studies illustrate the incidence of these therapies in neuronal activity. This work aims to study the feasibility of a virtual reality-based program oriented to the cognitive functions' rehabilitation of PD patients. For this, the study was divided in intervention with the program, acquisition of signals, data processing and results analysis.

The study highlights implementing new technologies to rehabilitate people with neurodegenerative diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nowadays, several strategies for treating neuropsychologic function loss in Parkinson disease (PD) have been proposed, such as physical activity performance and developing games to exercise the mind. However, few studies illustrate the incidence of these therapies in neuronal activity. This work aims to study the feasibility of a virtual reality-based program oriented to the cognitive functions' rehabilitation of PD patients. For this, the study was divided in intervention with the program, acquisition of signals, data processing and results analysis. The alpha and beta bands power behaviour were determined by evaluating the electroencephalography (EEG) signals obtained during the execution of control tests and games of the "Hand Physics Lab" Software, from which five games related to attention, planning, sequencing, concentration, and coordination, were taken.

The study highlights implementing new technologies to rehabilitate people with neurodegenerative diseases.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • XII Región
      • Punta Arenas, XII Región, Chile, 6211525
        • Corporación de Rehabilitación Club de Leones Cruz del Sur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parkinson Disease (Neurologist diagnosed)
  • Both gender
  • Informed consent accepted
  • Adults
  • Stage 2 and 3 in the Hoehn Yahr scale

Exclusion Criteria:

  • Mental diseases
  • Migraines
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention with virtual reality
Each subject will receive a single session of exercises with the OCULUS QUEST2 (OCULUS VR, USA) and a hand tracking software (Hand Physics Lab, Holonautic, Switzerland). Brain function monitoring will be made by an EEG system ENOBIO 20 (Neuro-electrics, Spain) positioned over subject head. Intervention consisted of exercises with upper limbs and visual feedback. These activities were projected stereoscopically on VR googles.
Device: Intervention with virtual reality

VR intervention with OCULUS QUEST2 (OCULUS VR, USA) consiste on a VR helmet positioned over subject head. The software consisted of a 3D environment with exercises of upper limbs and visual feedback for the treatment of cognitive and motor dysfunction. The therapist have real-time access to the activities in the 3D environment vby real-time video transmission of the helmet activity.

The program include a single session. Each session is monitored on safety aspects of the subjects with emphasis on possible side effects of virtual reality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Power spectral density in the frequency of motor imagery from primary motor cortex
Time Frame: Baseline
continuous signals will be acquired from the primary motor cortex of lower limbs (FcZ, C2, Cz, C1, Cpz) according to the 10-20 International EEG System. Power spectral density in the frequency band of motor imagery (8-32Hz) will be obtained by OpenVibe Software and Matlab. The measure unit is Decibels per Hertz(dB/Hz).
Baseline
Power spectral density in the frequency of motor imagery from primary motor cortex Post-Intervention
Time Frame: 2 weeks
continuous signals will be acquired from the primary motor cortex of lower limbs (FcZ, C2, Cz, C1, Cpz) according to the 10-20 International EEG System. Power spectral density in the frequency band of motor imagery (8-32Hz) will be obtained by OpenVibe Software and Matlab. The measure unit is Decibels per Hertz(dB/Hz).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporación de Rehabilitación Club de Leones Cruz del Sur

Collaborators

Universidad del Rosario
Colombian School of Engineering Julio Garavito

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ACTUAL)

March 1, 2022

Study Completion (ACTUAL)

March 31, 2022

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (ACTUAL)

June 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 3, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CorporacionRCLCS0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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