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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR group | Experimental | 12 consecutive weeks of physiotherapy + training with the IVR |
|
| Active control group | Active Comparator | 6 consecutive weeks of physiotherapy only, followed by 6 consecutive weeks of physiotherapy + training with the IVR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTC Viveâ„¢ 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). |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquim Ferreira, MD, PhD | CNS-Campus Neurologico | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNS-Campus Neurológico | Lisbon | Portugal |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |