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Completed

NCT Number: NCT06052930

Immersive Virtual Reality for the Non-pharmacological Management of Parkinson's Disease

The goal of this clinical trial is to evaluate the feasibility, safety and efficacy of an immersive virtual reality (IVR) exergaming using a head-mounted display in Parkinson's disease symptomatic control.

This is a parallel-group, single-blinded, randomized controlled trial. The intervention group perform 12 weeks of physiotherapy and IVR, whereas the control group have 6 weeks of physiotherapy only, followed by 6 weeks of physiotherapy and IVR. The primary outcome is the symptomatic effect of the intervention as measured by the change from baseline in Time Up and Go (TUG) test with cognitive dual-task (TUG cognitive).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CNS-Campus Neurológico

Lisbon, 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;
  • Able to provide written informed consent to participate in the study.

Exclusion criteria

  • Postural instability or freezing of gait in MED ON representing an increased risk of fall, according to the best clinical judgement;
  • A Montreal Cognitive Assessment (MoCA) score < 21;
  • Presence of severe visual loss that could interfere with the ability to see the VR simulation as well as vertigo, epilepsy and psychosis;
  • Unstable medical condition, including cardiovascular, pulmonary or musculoskeletal, that according to the clinician's judgment affect patients' ability to participate in the study;
  • 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

HTC Vive™ Pro

Device

A commercially available head-mounted display. Each VR session has approximately 20 minutes, performed 3 times per week.

Both groups maintain similar PD specialized physiotherapy sessions throughout the duration of the study (3 times per week, 60 minutes per session).

Primary outcomes

  1. Change from baseline to 6-week in TUG cognitive test

    Time frame: 6 week

    Change from baseline to 6-week in TUG cognitive test

Secondary outcomes

  1. Change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking

    Time frame: 6, 12 and 16 weeks

    Difference between groups in change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking

  2. Change from baseline to each evaluation time point in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Time frame: 6, 12 and 16 weeks

    Difference between groups in change from baseline to each evaluation time point in MDS-UPDRS

  3. Change from baseline to each evaluation time point in mini-Balance Evaluation Systems Test (mini-BEST test)

    Time frame: 6, 12 and 16 weeks

    Difference between groups in change from baseline to each evaluation time point in mini-BEST test

  4. Change from baseline to each evaluation time point in Montreal Cognitive Assessment (MoCA)

    Time frame: 6, 12 and 16 weeks

    Difference between groups in change from baseline to each evaluation time point in MoCA

  5. Change from baseline to each evaluation time point in Stroop test

    Time frame: 6, 12 and 16 weeks

    Difference between groups in change from baseline to each evaluation time point in Stroop test

  6. Change from baseline to each evaluation time point in Visual Object and Space Perception (VOSP) Battery (cube and fragmented letters)

    Time frame: 6, 12 and 16 weeks

    Difference between groups in change from baseline to each evaluation time point in VOSP-cube analysis and VOSP-fragmented letters

  7. Change from baseline to each evaluation time point in Parkinson's Disease Questionnaire-39 items (PDQ-39)

    Time frame: 6, 12 and 16 weeks

    Difference between groups in change from baseline to each evaluation time point in PDQ-39 score

  8. Change from baseline to each evaluation time point in Schwab and England (S&E) scale

    Time frame: 6, 12 and 16 weeks

    Difference between groups in change from baseline to each evaluation time point in S&E scale

  9. Change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity

    Time frame: 6, 12 and 16 weeks

    Difference between groups in change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity

  10. Change from baseline to each evaluation time point in BMI

    Time frame: 6, 12 and 16 weeks

    Difference between groups in change from baseline to each evaluation time point in BMI

  11. Occurrence of adverse events

    Time frame: 16 weeks

    Difference between groups in patient's safety

  12. Occurrence of cybersickness using the Simulator Sickness Questionnaire (SSQ)

    Time frame: 16 weeks

    Difference between groups in SSQ

  13. Patients' consideration on system usability using the System Usability Scale (SUS)

    Time frame: 1, 6, 12 and 16 weeks

    SUS after the 1st week using the IVR system and at each evaluation time point

  14. Patients' Borg perceived exertion

    Time frame: 16 weeks

    Difference between groups in perceived exertion

  15. Likert scale on patients' satisfaction using the virtual reality system

    Time frame: 12 weeks

    Difference between groups in patients' satisfaction

Sponsors and collaborators

Lead sponsor

Campus Neurológico Sénior

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2023
Registry last updated
Sep 25, 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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