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

Campus Neurológico Sénior

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Dolphin 2.0

Study type: Interventional

Funder types: Other

Identifiers

NCT04699617

CNS2021-01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Active arm

Experimental group

Description:

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.

Treatment:

Device: Dolphin 2.0

Delayed-start control arm

Active Comparator group

Description:

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.

Treatment:

Device: Dolphin 2.0