Parkinson DiseaseNCT07129304
Design And Analysis of The Effectiveness of CVRE VS Non-Immersive VR in the Rehabilitation of Parkinson
A study testing Collaborative Virtual Reality with Routine Physical Therapy and Non-Immersive Virtual Reality with Routine Physical Therapy in people with Parkinson Disease, run by Superior University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Collaborative Virtual Reality with Routine Physical Therapy and Non-Immersive Virtual Reality with Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPakistan
- Study dates
- 17 Apr 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province
Superior University CRC
Lahore, Punjab Province
About this study
Official 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
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.
Read the 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
- Being tested
- Collaborative Virtual Reality with Routine Physical Therapy, Non-Immersive Virtual Reality with Routine Physical Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Virtual Reality with Routine Physical TherapyCombination 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 TherapyCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Virtual Reality with Routine Physical Therapy | Experimental | Not described Receives: Combination Product: Collaborative Virtual Reality with Routine Physical Therapy |
| Non-Immersive Virtual Reality with Routine Physical Therapy | Experimental | Not described Receives: Combination Product: Non-Immersive Virtual Reality with Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's disease Rating Scale Part III
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.
Measured: 24 Months
Timed Up and Go Test
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.
Measured: 24 Months
Parkinson's Disease Fatigue Scale (PFS-16)
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
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start17 Apr 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129304
- Sponsor's protocol ID
- PhDRSW/Batch-Fall23/2227
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07129304
- Acronym / sponsor ID
- PhDRSW/Batch-Fall23/2227
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Virtual Reality with Routine Physical Therapy | Experimental | Combination Product: Collaborative Virtual Reality with Routine Physical Therapy |
| Non-Immersive Virtual Reality with Routine Physical Therapy | Experimental | Combination Product: Non-Immersive Virtual Reality with Routine Physical Therapy |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Virtual Reality with Routine Physical Therapypatients 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. | Combination product | Collaborative Virtual Reality with Routine Physical Therapy |
| Non-Immersive Virtual Reality with Routine Physical TherapyPatients 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. | Combination product | Non-Immersive Virtual Reality with Routine Physical Therapy |
Primary outcome
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Virtual Reality with Routine Physical Therapy and Non-Immersive Virtual Reality with Routine Physical Therapy in people with Parkinson Disease, run by Superior University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's disease Rating Scale Part III (time frame: 24 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.