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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06052930
Other study ID # CNS-11-2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 19, 2023
Est. completion date August 12, 2023

Study information

Verified date September 2023
Source Campus Neurológico Sénior
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 12, 2023
Est. primary completion date August 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
HTC Vive™ Pro
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).

Locations

Country Name City State
Portugal CNS-Campus Neurológico Lisboa

Sponsors (1)

Lead Sponsor Collaborator
Campus Neurológico Sénior

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline to 6-week in TUG cognitive test Change from baseline to 6-week in TUG cognitive test 6 week
Secondary 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
Secondary 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 6, 12 and 16 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Occurrence of adverse events Difference between groups in patient's safety 16 weeks
Secondary Occurrence of cybersickness using the Simulator Sickness Questionnaire (SSQ) Difference between groups in SSQ 16 weeks
Secondary 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
Secondary Patients' Borg perceived exertion Difference between groups in perceived exertion 16 weeks
Secondary Likert scale on patients' satisfaction using the virtual reality system Difference between groups in patients' satisfaction 12 weeks
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