NCT06052930

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

August 14, 2023

Last Update Submit

September 19, 2023

Conditions

Parkinson Disease

Keywords

Immersive virtual realityNeurorehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to 6-week in TUG cognitive test

    Change from baseline to 6-week in TUG cognitive test

    6 week

Secondary Outcomes (15)

  • 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)

    6, 12 and 16 weeks

  • Change from baseline to each evaluation time point in mini-Balance Evaluation Systems Test (mini-BEST test)

    6, 12 and 16 weeks

  • Change from baseline to each evaluation time point in Montreal Cognitive Assessment (MoCA)

    6, 12 and 16 weeks

  • Change from baseline to each evaluation time point in Stroop test

    6, 12 and 16 weeks

  • +10 more secondary outcomes

Study Arms (2)

VR group

EXPERIMENTAL

12 consecutive weeks of physiotherapy + training with the IVR

Device: HTC Vive™ Pro

Active control group

ACTIVE COMPARATOR

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

Device: HTC Vive™ Pro

Interventions

HTC Vive™ ProDEVICE

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 groupVR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNS-Campus Neurológico

Lisbon, Portugal

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Joaquim Ferreira, MD, PhD

    CNS-Campus Neurologico

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2023

First Posted

September 25, 2023

Study Start

January 19, 2023

Primary Completion

August 12, 2023

Study Completion

August 12, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations

PT(1)