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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Intervention with virtual reality
Sponsored by
Corporación de Rehabilitación Club de Leones Cruz del Sur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, virtual reality, cognitive functions, alpha band, beta band, cerebral lobes, electroencephalography

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Corporación de Rehabilitación Club de Leones Cruz del Sur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention with virtual reality

Arm Description

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.

Outcomes

Primary Outcome Measures

Power spectral density in the frequency of motor imagery from primary motor cortex
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).
Power spectral density in the frequency of motor imagery from primary motor cortex Post-Intervention
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).

Secondary Outcome Measures

Full Information

First Posted
May 27, 2022
Last Updated
May 31, 2022
Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
Collaborators
Colombian School of Engineering Julio Garavito, Universidad del Rosario
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1. Study Identification

Unique Protocol Identification Number
NCT05403788
Brief Title
Usability Study of a Neuropsychological Intervention Program Based on Virtual Reality in Adults With Parkinson's Disease
Official Title
Usability Study of a Neuropsychological Intervention Program Based on Virtual Reality in Adults With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
Collaborators
Colombian School of Engineering Julio Garavito, Universidad del Rosario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, virtual reality, cognitive functions, alpha band, beta band, cerebral lobes, electroencephalography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention with virtual reality
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intervention with virtual reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Power spectral density in the frequency of motor imagery from primary motor cortex
Description
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).
Time Frame
Baseline
Title
Power spectral density in the frequency of motor imagery from primary motor cortex Post-Intervention
Description
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).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricio E Barría Aburto, MSc.
Organizational Affiliation
Corporación de Rehabilitacion Club de Leones Cruz del Sur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporación de Rehabilitación Club de Leones Cruz del Sur
City
Punta Arenas
State/Province
XII Región
ZIP/Postal Code
6211525
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
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Usability Study of a Neuropsychological Intervention Program Based on Virtual Reality in Adults With Parkinson's Disease

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