Immersive Virtual Reality for the Non-pharmacological Management of Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: HTC Vive™ Pro
- Registration Number
- NCT06052930
- Lead Sponsor
- Campus Neurológico Sénior
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VR group HTC Vive™ Pro 12 consecutive weeks of physiotherapy + training with the IVR Active control group HTC Vive™ Pro 6 consecutive weeks of physiotherapy only, followed by 6 consecutive weeks of physiotherapy + training with the IVR
- Primary Outcome Measures
Name Time Method Change from baseline to 6-week in TUG cognitive test 6 week Change from baseline to 6-week in TUG cognitive test
- Secondary Outcome Measures
Name Time Method Patients' Borg perceived exertion 16 weeks Difference between groups in perceived exertion
Likert scale on patients' satisfaction using the virtual reality system 12 weeks Difference between groups in patients' satisfaction
Change from baseline to each evaluation time point in Parkinson's Disease Questionnaire-39 items (PDQ-39) 6, 12 and 16 weeks Difference between groups in change from baseline to each evaluation time point in PDQ-39 score
Change from baseline to each evaluation time point in BMI 6, 12 and 16 weeks Difference between groups in change from baseline to each evaluation time point in BMI
Occurrence of adverse events 16 weeks Difference between groups in patient's safety
Change from baseline to each evaluation time point in Schwab and England (S&E) scale 6, 12 and 16 weeks Difference between groups in change from baseline to each evaluation time point in S\&E scale
Change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking 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
Change from baseline to each evaluation time point in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 6, 12 and 16 weeks Difference between groups in change from baseline to each evaluation time point in MDS-UPDRS
Change from baseline to each evaluation time point in Stroop test 6, 12 and 16 weeks Difference between groups in change from baseline to each evaluation time point in Stroop test
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 Difference between groups in change from baseline to each evaluation time point in VOSP-cube analysis and VOSP-fragmented letters
Change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity 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
Patients' consideration on system usability using the System Usability Scale (SUS) 1, 6, 12 and 16 weeks SUS after the 1st week using the IVR system and at each evaluation time point
Change from baseline to each evaluation time point in Montreal Cognitive Assessment (MoCA) 6, 12 and 16 weeks Difference between groups in change from baseline to each evaluation time point in MoCA
Occurrence of cybersickness using the Simulator Sickness Questionnaire (SSQ) 16 weeks Difference between groups in SSQ
Change from baseline to each evaluation time point in mini-Balance Evaluation Systems Test (mini-BEST test) 6, 12 and 16 weeks Difference between groups in change from baseline to each evaluation time point in mini-BEST test
Trial Locations
- Locations (1)
CNS-Campus Neurológico
🇵🇹Lisboa, Portugal