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

NCT ID: NCT07129304

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2027-03-01

Brief Summary

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.

Detailed Description

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Collaborative Virtual Reality with Routine Physical Therapy

Group Type: EXPERIMENTAL

Collaborative Virtual Reality with Routine Physical Therapy

Intervention Type: 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

Group Type: EXPERIMENTAL

Non-Immersive Virtual Reality with Routine Physical Therapy

Intervention Type: 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.

Interventions

Collaborative Virtual Reality with Routine Physical Therapy

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.

Intervention Type: COMBINATION_PRODUCT

Non-Immersive Virtual Reality with Routine Physical Therapy

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Superior University CRC

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

PhDRSW/Batch-Fall23/2227

Identifier Type: -

Identifier Source: org_study_id