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NCT Number: NCT07129304

Design And Analysis of The Effectiveness of CVRE VS Non-Immersive VR in the Rehabilitation of Parkinson

This study is being conducted to investigate the effect of Collaborative Virtual Reality Environments versus non-immersive Virtual reality-based rehabilitation in addition to the conventional Physical Therapy for patients with Parkinson's Disease to improve the motor, cognitive function, and overall quality of life.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University, Lahore, Punjab Province, Pakistan

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About this study

Parkinson's Disease is a progressive, neurodegenerative disorder with sign and symptoms of resting tremor, rigidity, retropulsion, stooping posture, sluggishness of spontaneous actions, with masked face. Parkinson's disease is increasing worldwide every year. Besides medical or surgical treatment, task-oriented Physical Therapy exercises have shown improvement in balance, reducing falls, and enhancing motor functions. Virtual reality (VR) has also appeared to be a promising means for rehabilitation in this disease. Collaborative Virtual Environments are shared digital spaces that enable real-time collaboration and interaction, often represented through avatars. Rehabilitation treatment with such advanced virtual reality technology i.e., comparing Collaborative Virtual Environments (CVEs) and Non-Immersive Virtual Reality to enhance motor functions along with cognitive tasks in Parkinson's disease may transform Physiotherapy rehabilitation by advocating engaging, effective, and scalable interventions, ultimately improving the outcomes and quality of life in Parkinson's disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gender: Both Male and Female genders patients
  • Age Range: 40 years -80 Years
  • Diagnosis: Clinically diagnosed patients of idiopathic Parkinson Disease classified as mild to moderate severity according to the modified Hoehn & Yahr stages I-III.
  • Cognitive Function: Adequate cognitive function as assessed by Mini Mental State Examination (score ≥ 24)
  • Functional Ability: can walk independently, must have sufficient physical and cognitive ability to engage in virtual rehabilitation sessions.

Exclusion criteria

  • History of any neurological conditions other than Parkinson's disease.
  • History of visual auditory, or motor impairments unrelated to Parkinson's Disease.
  • History of orthopedic injury leading to complications like any deformity.
  • Diagnosed phobia of virtual environment.
  • Comorbidities that hinder participation in the treatment (e.g., advanced dementia).
  • Patient taking another medication affecting neurological condition.

Treatment and study plan

Collaborative Virtual Reality with Routine Physical Therapy

Combination Product

patients will receive routine Physiotherapy treatment and additional treatment in a Collaborative Virtual Reality Environment for 30 minutes per session 3 times /week for minimum of 8 weeks. There will be a real time interaction in this group between patients and Physiotherapist in the virtual environment. The tasks in the CVE will focus on motor control, balance, coordination, and social engagement while routine Physical Therapy session will consist of performing exercises based on similar goals of improving motor skills, enhanced coordination, functional mobility, muscle strength and stretching exercises.

Non-Immersive Virtual Reality with Routine Physical Therapy

Combination Product

Patients will receive routine physiotherapy treatment along with the engagement with computer-based virtual rehabilitation content displayed on a standard computer monitor/ LED screen. There will be no real time interaction in this group between patients and Physiotherapist in the virtual environment. Patients will be viewing pre-recorded videos of therapeutic exercises, demonstration, and / or on-screen instructions and cues for performing exercises. This group's patients will be treated with non- immersive virtual reality along with routine physical therapy for 30 minutes session 3 times /week for 8 weeks. Routine Physical Therapy session will consist of performing exercise based on the goal of improving motor skills, enhanced coordination, posture correction, gait efficiency, functional mobility, muscle strength and endurance training, stretching exercises where required.

Primary outcomes

  1. Unified Parkinson's disease Rating Scale Part III

    Time frame: 24 Months

    The UPDRS Part III is a tool frequently employed in clinical settings to assess the motor functions of individuals with Parkinson's Disease. It encompasses a series of 31 items, which specifically evaluate motor symptoms such as tremor, rigidity, bradykinesia (slowness of movement), postural instability, and other related motor impairments.

    • Scoring: Total score range: 0 to 199. Higher scores indicate more severe motor dysfunction and greater disability.

  2. Timed Up and Go Test

    Time frame: 24 Months

    The TUG test is a simple and effective measure of physical mobility, balance, and the risk of falls in individuals, especially those with Parkinson's Disease. It involves timing how long it takes a person to rise from a chair, walk 3 meters, turn around, walk back, and sit down again. The total time taken to complete the test is recorded in seconds.

    • Longer times suggest greater difficulty with mobility, balance, and overall motor function, which may indicate a higher fall risk and greater disability.

  3. Parkinson's Disease Fatigue Scale (PFS-16)

    Time frame: 24 Months

    The PFS-16 is a self-reported tool that helps to assess the level of fatigue experienced by individuals with Parkinson's Disease. It consists of 16 questions that cover the frequency and impact of fatigue on daily life.

    • Scoring: Each item is rated on a scale from 1 to 5, where 1 = never and 5 = always. Total score range: 16 to 80

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Design And Analysis of The Effectiveness of Collaborative Virtual Reality Environment Versus Non-Immersive Virtual Reality in the Rehabilitation of Patients With Parkinson's Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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