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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: HTC Vive™ Pro

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal
    • CNS-Campus Neurológico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR group; 12 consecutive weeks of physiotherapy + training with the IVR	Device: HTC Vive™ Pro; 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).
Active Comparator: Active control group; 6 consecutive weeks of physiotherapy only, followed by 6 consecutive weeks of physiotherapy + training with the IVR	Device: HTC Vive™ Pro; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to 6-week in TUG cognitive test	Change from baseline to 6-week in TUG cognitive test	6 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking	Difference between groups in change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking	6, 12 and 16 weeks
Change from baseline to each evaluation time point in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Difference between groups in change from baseline to each evaluation time point in MDS-UPDRS	6, 12 and 16 weeks
Change from baseline to each evaluation time point in mini-Balance Evaluation Systems Test (mini-BEST test)	Difference between groups in change from baseline to each evaluation time point in mini-BEST test	6, 12 and 16 weeks
Change from baseline to each evaluation time point in Montreal Cognitive Assessment (MoCA)	Difference between groups in change from baseline to each evaluation time point in MoCA	6, 12 and 16 weeks
Change from baseline to each evaluation time point in Stroop test	Difference between groups in change from baseline to each evaluation time point in Stroop test	6, 12 and 16 weeks
Change from baseline to each evaluation time point in Visual Object and Space Perception (VOSP) Battery (cube and fragmented letters)	Difference between groups in change from baseline to each evaluation time point in VOSP-cube analysis and VOSP-fragmented letters	6, 12 and 16 weeks
Change from baseline to each evaluation time point in Parkinson's Disease Questionnaire-39 items (PDQ-39)	Difference between groups in change from baseline to each evaluation time point in PDQ-39 score	6, 12 and 16 weeks
Change from baseline to each evaluation time point in Schwab and England (S&E) scale	Difference between groups in change from baseline to each evaluation time point in S&E scale	6, 12 and 16 weeks
Change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity	Difference between groups in change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity	6, 12 and 16 weeks
Change from baseline to each evaluation time point in BMI	Difference between groups in change from baseline to each evaluation time point in BMI	6, 12 and 16 weeks
Occurrence of adverse events	Difference between groups in patient's safety	16 weeks
Occurrence of cybersickness using the Simulator Sickness Questionnaire (SSQ)	Difference between groups in SSQ	16 weeks
Patients' consideration on system usability using the System Usability Scale (SUS)	SUS after the 1st week using the IVR system and at each evaluation time point	1, 6, 12 and 16 weeks
Patients' Borg perceived exertion	Difference between groups in perceived exertion	16 weeks
Likert scale on patients' satisfaction using the virtual reality system	Difference between groups in patients' satisfaction	12 weeks

Collaborators and Investigators

• Sponsor: Campus Neurológico Sénior
• Investigators: Study Director: Joaquim Ferreira, MD, PhD, CNS-Campus Neurológico

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): August 12, 2023
• Study Completion (Actual): August 12, 2023

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Neurorehabilitation; Immersive virtual reality
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CNS-11-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No