Back to resultsImmersive Virtual Reality for the Non-pharmacological Management of Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
HTC Vive™ Pro
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Immersive virtual reality, Neurorehabilitation
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.
Sites / Locations
- CNS-Campus Neurológico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VR group
Active control group
Arm Description
12 consecutive weeks of physiotherapy + training with the IVR
6 consecutive weeks of physiotherapy only, followed by 6 consecutive weeks of physiotherapy + training with the IVR
Outcomes
Primary Outcome Measures
Change from baseline to 6-week in TUG cognitive test
Change from baseline to 6-week in TUG cognitive test
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
Change from baseline to each evaluation time point in BMI
Difference between groups in change from baseline to each evaluation time point in BMI
Occurrence of adverse events
Difference between groups in patient's safety
Occurrence of cybersickness using the Simulator Sickness Questionnaire (SSQ)
Difference between groups in SSQ
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
Patients' Borg perceived exertion
Difference between groups in perceived exertion
Likert scale on patients' satisfaction using the virtual reality system
Difference between groups in patients' satisfaction
Full Information
NCT ID
NCT06052930
First Posted
August 14, 2023
Last Updated
September 19, 2023
Sponsor
Campus Neurológico Sénior
1. Study Identification
Unique Protocol Identification Number
NCT06052930
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
August 12, 2023 (Actual)
Study Completion Date
August 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Campus Neurológico Sénior
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Immersive virtual reality, Neurorehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VR group
Arm Type
Experimental
Arm Description
12 consecutive weeks of physiotherapy + training with the IVR
Arm Title
Active control group
Arm Type
Active Comparator
Arm Description
6 consecutive weeks of physiotherapy only, followed by 6 consecutive weeks of physiotherapy + training with the IVR
Intervention Type
Device
Intervention Name(s)
HTC Vive™ Pro
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline to 6-week in TUG cognitive test
Description
Change from baseline to 6-week in TUG cognitive test
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking
Description
Difference between groups in change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking
Time Frame
6, 12 and 16 weeks
Title
Change from baseline to each evaluation time point in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
Difference between groups in change from baseline to each evaluation time point in MDS-UPDRS
Time Frame
6, 12 and 16 weeks
Title
Change from baseline to each evaluation time point in mini-Balance Evaluation Systems Test (mini-BEST test)
Description
Difference between groups in change from baseline to each evaluation time point in mini-BEST test
Time Frame
6, 12 and 16 weeks
Title
Change from baseline to each evaluation time point in Montreal Cognitive Assessment (MoCA)
Description
Difference between groups in change from baseline to each evaluation time point in MoCA
Time Frame
6, 12 and 16 weeks
Title
Change from baseline to each evaluation time point in Stroop test
Description
Difference between groups in change from baseline to each evaluation time point in Stroop test
Time Frame
6, 12 and 16 weeks
Title
Change from baseline to each evaluation time point in Visual Object and Space Perception (VOSP) Battery (cube and fragmented letters)
Description
Difference between groups in change from baseline to each evaluation time point in VOSP-cube analysis and VOSP-fragmented letters
Time Frame
6, 12 and 16 weeks
Title
Change from baseline to each evaluation time point in Parkinson's Disease Questionnaire-39 items (PDQ-39)
Description
Difference between groups in change from baseline to each evaluation time point in PDQ-39 score
Time Frame
6, 12 and 16 weeks
Title
Change from baseline to each evaluation time point in Schwab and England (S&E) scale
Description
Difference between groups in change from baseline to each evaluation time point in S&E scale
Time Frame
6, 12 and 16 weeks
Title
Change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity
Description
Difference between groups in change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity
Time Frame
6, 12 and 16 weeks
Title
Change from baseline to each evaluation time point in BMI
Description
Difference between groups in change from baseline to each evaluation time point in BMI
Time Frame
6, 12 and 16 weeks
Title
Occurrence of adverse events
Description
Difference between groups in patient's safety
Time Frame
16 weeks
Title
Occurrence of cybersickness using the Simulator Sickness Questionnaire (SSQ)
Description
Difference between groups in SSQ
Time Frame
16 weeks
Title
Patients' consideration on system usability using the System Usability Scale (SUS)
Description
SUS after the 1st week using the IVR system and at each evaluation time point
Time Frame
1, 6, 12 and 16 weeks
Title
Patients' Borg perceived exertion
Description
Difference between groups in perceived exertion
Time Frame
16 weeks
Title
Likert scale on patients' satisfaction using the virtual reality system
Description
Difference between groups in patients' satisfaction
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquim Ferreira, MD, PhD
Organizational Affiliation
CNS-Campus Neurologico
Official's Role
Study Director
Facility Information:
Facility Name
CNS-Campus Neurológico
City
Lisboa
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
Immersive Virtual Reality for the Non-pharmacological Management of Parkinson's Disease
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