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Completed

NCT Number: NCT04699617

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Neurológico Sénior

Torres Vedras, 2560-280, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dolphin 2.0

Device

The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures.

Primary outcomes

  1. Time reduction in seconds in the Time Up and Go (TUG) test (early intervention effect)

    Time frame: 6-weeks (T1)

    Early intervention effect: superiority of active versus control group with respect to TUG at 6 weeks

Secondary outcomes

  1. Time reduction in seconds in the TUG test (late intervention effect)

    Time frame: 12-weeks (T2) and 16-weeks (T3)

    Late intervention effect: superiority of active group versus control group with respect to TUG result at 12 and 16-weeks

  2. Change in MDS-UPDRS

    Time frame: Baseline, 6-week, 12-week and 16-week

    Difference between groups in MDS-UPDRS

  3. Change in Mini-best test

    Time frame: Baseline, 6-week, 12-week and 16-week

    Difference between groups in Mini-best test

  4. Change in SCOPA-Cog

    Time frame: at baseline and 16-week

    Difference between groups in SCOPA-Cog

  5. Change in PDQ-39 score

    Time frame: at baseline and and 12-week

    Difference between groups in PDQ-39 score

  6. Change in Clinical Global Improvement

    Time frame: Baseline, 6-week, 12-week and 16-week

    Difference between groups in Clinical Global Improvement

  7. Change in Patient Global Impression - Change

    Time frame: Baseline, 6-week, 12-week and 16-week

    Difference between groups in Patient Global Impression - Change

  8. System Usability Scale

    Time frame: after the 1st session of 1st week and the last sessions of 6th and 12th weeks

    Difference between groups in System Usability Scale

  9. Simulator Sickness Questionnaire

    Time frame: after the 1st session of 1st week and the last sessions of 6th and 12th weeks

    Difference between groups in Simulator Sickness Questionnaire

  10. Number of steps/day

    Time frame: Baseline, 6-week, 12-week and 16-week

    Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity)

  11. Time spent in each level of activity

    Time frame: Baseline, 6-week, 12-week and 16-week

    Difference between groups in Patients' level of physical activity (number of steps/day, time spent in each level of activity)

  12. Change in BMI

    Time frame: Baseline, 6-week, 12-week and 16-week

    Difference between groups in BMI

  13. Change in Schwab and England scale

    Time frame: at baseline and 12-week

    Difference between groups in Schwab and England scale

  14. Patients' satisfaction and perceived exertion

    Time frame: after the 1st session of 1st week and the last sessions of 6th and 12th weeks

    Difference between groups in Patients' satisfaction and perceived exertion (7-points Likert scale)

Sponsors and collaborators

Lead sponsor

Campus Neurológico Sénior

Other

Collaborators

  • Johns Hopkins University

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2021
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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