Clinical trial NCT04699617: The Feasibility and Efficacy of an Immersive Virtual Reality Software in Parkinson's Disease Patients
Official title: The Feasibility and Efficacy of an Immersive Virtual Reality Software in Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Campus Neurológico Sénior
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2021-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time reduction in seconds in the Time Up and Go (TUG) test (early intervention effect)
timeFrame: 6-weeks (T1)
Secondary outcomes:
measure: Time reduction in seconds in the TUG test (late intervention effect)
timeFrame: 12-weeks (T2) and 16-weeks (T3)
measure: Change in MDS-UPDRS
timeFrame: Baseline, 6-week, 12-week and 16-week
measure: Change in Mini-best test
timeFrame: Baseline, 6-week, 12-week and 16-week
measure: Change in SCOPA-Cog
timeFrame: at baseline and 16-week
measure: Change in PDQ-39 score
timeFrame: at baseline and and 12-week
measure: Change in Clinical Global Improvement
timeFrame: Baseline, 6-week, 12-week and 16-week
measure: Change in Patient Global Impression - Change
timeFrame: Baseline, 6-week, 12-week and 16-week
measure: System Usability Scale
timeFrame: after the 1st session of 1st week and the last sessions of 6th and 12th weeks
measure: Simulator Sickness Questionnaire
timeFrame: after the 1st session of 1st week and the last sessions of 6th and 12th weeks
measure: Number of steps/day
timeFrame: Baseline, 6-week, 12-week and 16-week
measure: Time spent in each level of activity
timeFrame: Baseline, 6-week, 12-week and 16-week
measure: Change in BMI
timeFrame: Baseline, 6-week, 12-week and 16-week
measure: Change in Schwab and England scale
timeFrame: at baseline and 12-week
measure: Patients' satisfaction and perceived exertion
timeFrame: after the 1st session of 1st week and the last sessions of 6th and 12th weeks
Other outcomes:
Locations:
city: Torres Vedras
country: Portugal
facility: Campus Neurológico Sénior
Study officials:
affiliation: CNS - Campus Neurológico
name: Joaquim Ferreira, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: