Clinical trial NCT06052930: Immersive Virtual Reality for the Non-pharmacological Management of Parkinson's Disease
Official title: Immersive Virtual Reality for the Non-pharmacological Management of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Immersive virtual reality
Neurorehabilitation
Lead sponsor: Campus Neurológico Sénior
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change from baseline to 6-week in TUG cognitive test
timeFrame: 6 week
Secondary outcomes:
measure: Change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking
timeFrame: 6, 12 and 16 weeks
measure: Change from baseline to each evaluation time point in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 6, 12 and 16 weeks
measure: Change from baseline to each evaluation time point in mini-Balance Evaluation Systems Test (mini-BEST test)
timeFrame: 6, 12 and 16 weeks
measure: Change from baseline to each evaluation time point in Montreal Cognitive Assessment (MoCA)
timeFrame: 6, 12 and 16 weeks
measure: Change from baseline to each evaluation time point in Stroop test
timeFrame: 6, 12 and 16 weeks
measure: Change from baseline to each evaluation time point in Visual Object and Space Perception (VOSP) Battery (cube and fragmented letters)
timeFrame: 6, 12 and 16 weeks
measure: Change from baseline to each evaluation time point in Parkinson's Disease Questionnaire-39 items (PDQ-39)
timeFrame: 6, 12 and 16 weeks
measure: Change from baseline to each evaluation time point in Schwab and England (S&E) scale
timeFrame: 6, 12 and 16 weeks
measure: Change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity
timeFrame: 6, 12 and 16 weeks
measure: Change from baseline to each evaluation time point in BMI
timeFrame: 6, 12 and 16 weeks
measure: Occurrence of adverse events
timeFrame: 16 weeks
measure: Occurrence of cybersickness using the Simulator Sickness Questionnaire (SSQ)
timeFrame: 16 weeks
measure: Patients' consideration on system usability using the System Usability Scale (SUS)
timeFrame: 1, 6, 12 and 16 weeks
measure: Patients' Borg perceived exertion
timeFrame: 16 weeks
measure: Likert scale on patients' satisfaction using the virtual reality system
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: CNS-Campus Neurológico
Study officials:
affiliation: CNS-Campus Neurologico
name: Joaquim Ferreira, MD, PhD
role: STUDY_DIRECTOR
References: