Immersive Virtual Reality for the Non-pharmacological Management of Parkinson's Disease

NCT ID: NCT06052930

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2023-08-12

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).

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR group

12 consecutive weeks of physiotherapy + training with the IVR

Group Type: EXPERIMENTAL

HTC Vive™ Pro

Intervention Type: 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).

Active control group

6 consecutive weeks of physiotherapy only, followed by 6 consecutive weeks of physiotherapy + training with the IVR

Group Type: ACTIVE_COMPARATOR

HTC Vive™ Pro

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Neurológico Sénior

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joaquim Ferreira, MD, PhD

Role: STUDY_DIRECTOR

CNS-Campus Neurologico

Locations

CNS-Campus Neurológico

Lisbon, , Portugal

Countries

Portugal

Other Identifiers

CNS-11-2022

Identifier Type: -

Identifier Source: org_study_id