NCT07523425

Brief Summary

This randomized controlled trial aims to compare the effectiveness of a Collaborative Virtual Reality Environment (CVE) and Non-Immersive Virtual Reality (NIVR) in the rehabilitation of patients with Parkinson's disease. Participants with mild to moderate disease severity will be randomly assigned to either the CVE group or the NIVR group. The CVE intervention will involve therapist-guided, interactive virtual exercises in a shared environment, promoting real-time engagement and feedback. The NIVR group will perform task-oriented exercises using screen-based virtual reality without immersive and collaborative features. Both interventions will be delivered over an 12-week period. Primary outcomes will assess motor function using standardized clinical scales, while secondary outcomes will evaluate cognitive function, mobility, and quality of life. The study seeks to determine whether collaborative and interactive virtual rehabilitation provides superior clinical outcomes compared to conventional non-immersive virtual approaches in patients with Parkinson's disease.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress66%
May 2025Sep 2026

Study Start

First participant enrolled

May 27, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2026

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 5, 2026

Last Update Submit

April 11, 2026

Conditions

Keywords

Parkinson DiseaseCollaborative Virtual Reality EvinronmentNon Immersive Virtual RealityRehabilitationMotor Control

Outcome Measures

Primary Outcomes (2)

  • MDS-UPDRS-III

    The MDS-UPDRS-III is a clinician-administered scale used to assess motor impairment in individuals with Parkinson's disease. It evaluates key domains including bradykinesia, rigidity, tremor, postural stability, and gait through a series of standardized physical examination items. Each item is scored on a 5-point ordinal scale ranging from 0 (normal) to 4 (severe impairment), with higher total scores indicating greater motor dysfunction. The scale provides a comprehensive measure of motor severity and is widely used in both clinical and research settings due to its strong reliability and validity. Changes in MDS-UPDRS-III scores over time will be used to determine the effectiveness of the intervention in improving motor function.

    From enrollment to the end of treatment at12 weeks

  • Timed Up and Go (TUG) Test

    The Timed Up and Go (TUG) Test is a standardized clinical measure used to assess functional mobility, balance, and risk of falls in individuals with Parkinson's disease. The test requires the participant to stand up from a seated position, walk a distance of approximately 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete the task is recorded in seconds. Shorter completion times indicate better functional mobility and balance performance, whereas longer times may reflect impaired mobility and increased fall risk. The TUG test is widely recognized for its simplicity, reliability, and sensitivity to changes following rehabilitation interventions.

    Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)

Secondary Outcomes (3)

  • Falls Efficacy Scale-International (FES-I)

    Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)

  • Parkinson's Disease Fatigue Scale (PFS-16)

    Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)

  • Action Research Arm Test (ARAT)

    Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)

Study Arms (2)

CVE

EXPERIMENTAL

Participants in this arm will receive rehabilitation through a Collaborative Virtual Reality Environment (CVE), where both the patient and therapist interact simultaneously within a shared virtual space. The intervention is delivered using a head-mounted display-based system that enables real-time communication, guidance, and feedback. The rehabilitation program consists of task-specific, goal-oriented exercises targeting upper limb function, gait, balance, and functional mobility. Activities are designed to simulate real-world movements and include object manipulation, reaching tasks, and controlled walking scenarios. The therapist actively supervises and adapts the exercises during each session, ensuring appropriate progression based on patient performance. The collaborative nature of the environment facilitates increased engagement, motor learning, and adherence by incorporating interactive elements and immediate corrective feedback. The intervention follows structured progressio

Other: Collaborative Virtual Environment

NIVR

OTHER

Participants in this arm will undergo rehabilitation using a Non-Immersive Virtual Reality (NIVR) system delivered through a standard screen-based interface. The intervention without the use of head-mounted displays or real-time collaborative features. The rehabilitation program includes task-oriented exercises focusing on upper limb function, balance, gait-related activities, and overall functional mobility. These exercises are designed to replicate real-world movements and are performed in a structured and repetitive manner to promote motor learning. Participants will perform the activities independently with periodic supervision from a therapist. Feedback is primarily system-generated, and progression is based on predefined levels of difficulty within the software. The intervention emphasizes consistency, task specificity, and gradual progression throughout the study

Other: Non-Immersive Virtual Reality (NIVR)

Interventions

Collaborative Virtual Reality Environment (CVE), participants perform exercises within a shared virtual space alongside a therapist, enabling real-time interaction, guidance, and adaptive feedback.

CVE

Physiotherapy-based rehabilitation delivered through a screen-based virtual environment, involving structured, task-oriented exercises performed with limited therapist interaction

NIVR

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and Female
  • Age: 45 years-80 Years
  • Diagnosed patients of idiopathic Parkinson Disease with minor to moderate severity according to the Hoehn \& Yahr stages I-III.
  • On conventional and stable medical treatment at present
  • No severe cognitive impairments (MMSE ≥ 24).
  • Ability to participate in virtual rehabilitation sessions
  • Willingness to participate and provide informed consent

You may not qualify if:

  • Severe visual, auditory, or motor impairments unrelated to Parkinson's.
  • Fear of virtual environment.
  • Comorbidities that hinder participation in the treatment (e.g., advanced dementia).
  • Severe musculoskeletal conditions limiting movement
  • History of epilepsy or conditions contraindicating virtual reality exposure
  • Participation in another interventional study within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Punjab Institute of Neurosciences Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hafiz Muddassir Riaz

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded for the purpose of avoiding biase
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Two parallel group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (PI)

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 13, 2026

Study Start

May 27, 2025

Primary Completion (Estimated)

September 27, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations