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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699617
• Other study ID #: CNS2021-01
• Status: Completed
• Phase: N/A
• Start date: December 28, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2023
• Source: Campus Neurológico Sénior
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Portugal	Campus Neurológico Sénior	Torres Vedras

Sponsors (2)

Lead Sponsor	Collaborator
Campus Neurológico Sénior	Johns Hopkins University

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Change in MDS-UPDRS	Difference between groups in MDS-UPDRS	Baseline, 6-week, 12-week and 16-week
Secondary	Change in Mini-best test	Difference between groups in Mini-best test	Baseline, 6-week, 12-week and 16-week
Secondary	Change in SCOPA-Cog	Difference between groups in SCOPA-Cog	at baseline and 16-week
Secondary	Change in PDQ-39 score	Difference between groups in PDQ-39 score	at baseline and and 12-week
Secondary	Change in Clinical Global Improvement	Difference between groups in Clinical Global Improvement	Baseline, 6-week, 12-week and 16-week
Secondary	Change in Patient Global Impression - Change	Difference between groups in Patient Global Impression - Change	Baseline, 6-week, 12-week and 16-week
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in BMI	Difference between groups in BMI	Baseline, 6-week, 12-week and 16-week
Secondary	Change in Schwab and England scale	Difference between groups in Schwab and England scale	at baseline and 12-week
Secondary	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