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

Campus Neurológico Sénior1 site in 1 country30 target enrollmentJanuary 19, 2023

ConditionsParkinson Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Campus Neurológico Sénior
Enrollment: 30
Locations: 1
Primary Endpoint: Change from baseline to 6-week in TUG cognitive test
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

January 19, 2023

End Date

August 12, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Campus Neurológico Sénior

Responsible Party

Sponsor

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;
•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.

Outcomes

Primary Outcomes

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

Change from baseline to each evaluation time point in Parkinson's Disease Questionnaire-39 items (PDQ-39)(6, 12 and 16 weeks)
Change from baseline to each evaluation time point in BMI(6, 12 and 16 weeks)
Occurrence of adverse events(16 weeks)
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)(6, 12 and 16 weeks)
Change from baseline to each evaluation time point in Schwab and England (S&E) scale(6, 12 and 16 weeks)
Patients' Borg perceived exertion(16 weeks)
Likert scale on patients' satisfaction using the virtual reality system(12 weeks)
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)(6, 12 and 16 weeks)
Change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity(6, 12 and 16 weeks)
Patients' consideration on system usability using the System Usability Scale (SUS)(1, 6, 12 and 16 weeks)
Change from baseline to each evaluation time point in Montreal Cognitive Assessment (MoCA)(6, 12 and 16 weeks)
Occurrence of cybersickness using the Simulator Sickness Questionnaire (SSQ)(16 weeks)
Change from baseline to each evaluation time point in mini-Balance Evaluation Systems Test (mini-BEST test)(6, 12 and 16 weeks)