The Feasibility and Efficacy of an Immersive Virtual Reality Software in Parkinson's Disease Patients

The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures (dolphin, orca, axolotl). Video games lead to high levels of motivation and arousal, provide immediate feedback and playback, provide explicit reward and implicit success, and titrate difficulty levels. This encourages the practice of exercise, being an important complement to physiotherapy sessions.

The main goal of this study is to evaluate the feasibility, safety and efficacy of an immersive virtual reality software (Dolphin, 2.0) in Parkinson's disease symptomatic control, in a two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Dolphin 2.0

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Torres Vedras, Portugal, 2560-280
    • Campus Neurológico Sénior

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with Parkinson's disease according to MDS criteria;
• Hoehn and Yahr stages between I-III (MED ON);
• Ability to perform the Time Up and Go test in normal pace and without assistance, in less than 11,5 seconds in ON state;
• Stable medication for the past 1 month
• Ability to communicate with the investigator, to understand and comply with the requirements of the study;
• Willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

• History of falls (1 fall in the 3 previous months);
• Psychiatric major co-morbidity (e.g., major depressive disorder as determined by DSM IV criteria);
• A Montreal Cognitive Assessment (MoCA) score < 21;
• Significant visual or visual-perceptual deficits or neuropsychological impairments that may limit participation in the protocol;
• Having any other neurological/orthopaedic disorders likely to affect gait or exercise capacity, e.g., history of stroke;
• Unstable medical condition including cardiovascular instability in the past 6 months
• Interfering activities performed at high level (sports);
• Inability to correctly respond to the assessment protocol according to the clinician's judgment or lack of support from caregiver for this effect.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active arm; The active arm will include 3 days a week of training with the Dolphin 2.0 for 12 consecutive weeks. Each session will have the duration of 60 minutes.	Device: Dolphin 2.0; The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures.
Active Comparator: Delayed-start control arm; The delayed-start control arm will have six-weeks of physiotherapy specialized for PD (3 times/week, 60 minutes/session) and six-weeks of 3 days a week of training with the Dolphin 2.0, with sessions of 60 minutes.	Device: Dolphin 2.0; The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time reduction in seconds in the Time Up and Go (TUG) test (early intervention effect)	Early intervention effect: superiority of active versus control group with respect to TUG at 6 weeks	6-weeks (T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time reduction in seconds in the TUG test (late intervention effect)	Late intervention effect: superiority of active group versus control group with respect to TUG result at 12 and 16-weeks	12-weeks (T2) and 16-weeks (T3)
Change in MDS-UPDRS	Difference between groups in MDS-UPDRS	Baseline, 6-week, 12-week and 16-week
Change in Mini-best test	Difference between groups in Mini-best test	Baseline, 6-week, 12-week and 16-week
Change in SCOPA-Cog	Difference between groups in SCOPA-Cog	at baseline and 16-week
Change in PDQ-39 score	Difference between groups in PDQ-39 score	at baseline and and 12-week
Change in Clinical Global Improvement	Difference between groups in Clinical Global Improvement	Baseline, 6-week, 12-week and 16-week
Change in Patient Global Impression - Change	Difference between groups in Patient Global Impression - Change	Baseline, 6-week, 12-week and 16-week
System Usability Scale	Difference between groups in System Usability Scale	after the 1st session of 1st week and the last sessions of 6th and 12th weeks
Simulator Sickness Questionnaire	Difference between groups in Simulator Sickness Questionnaire	after the 1st session of 1st week and the last sessions of 6th and 12th weeks
Number of steps/day	Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity)	Baseline, 6-week, 12-week and 16-week
Time spent in each level of activity	Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity)	Baseline, 6-week, 12-week and 16-week
Change in BMI	Difference between groups in BMI	Baseline, 6-week, 12-week and 16-week
Change in Schwab and England scale	Difference between groups in Schwab and England scale	at baseline and 12-week
Patients' satisfaction and perceived exertion	Difference between groups in Patients' satisfaction and perceived exertion (7-points Likert scale)	after the 1st session of 1st week and the last sessions of 6th and 12th weeks

Collaborators and Investigators

• Sponsor: Campus Neurológico Sénior
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Joaquim Ferreira, MD,PhD, CNS - Campus Neurológico

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CNS2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The methodology followed and the results of the study will be shared at the end through publication in a peer-review journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No