Parkinson DeseaseCVE vs NIVRNCT07523425
Collaborative vs Non-Immersive VR in Parkinson's Rehabilitation
A study testing Collaborative Virtual Environment and Non-Immersive Virtual Reality (NIVR) in people with Parkinson Desease, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson Desease
- What is being tested?
- Collaborative Virtual Environment and Non-Immersive Virtual Reality (NIVR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 27 May 2025to 30 Sep 2026
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Punjab Institute of Neurosciences Lahore
Lahore, Punjab Province, 54000
About this study
Official title: COMPARATIVE EFFECTIVENESS of COLLABORATIVE VIRTUAL ENVIRONMENT and NON-IMMERSIVE VIRTUAL REALITY in the REHABILITATION of PATIENTS With PARKINSON'S DISEASE
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.
Read more
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.
Read the detailed description
This study is designed to investigate the comparative therapeutic value of two distinct virtual reality-based rehabilitation teatement in individuals diagnosed with Parkinson's disease. The focus is on understanding how differences in interaction design, immersion level, and therapist involvement influence clinical outcomes.
The intervention framework is structured around task-oriented, goal-directed activities targeting both motor and cognitive domains commonly affected in Parkinson's disease. The Collaborative Virtual Reality Environment (CVE) incorporates a shared virtual space where the patient and therapist interact synchronously. This setup enables real-time guidance, adaptive feedback, and enhanced engagement through social and therapeutic presence. In contrast, the Non-Immersive Virtual Reality (NIVR) condition delivers similar rehabilitation tasks via a conventional screen-based interface without immersive or collaborative elements, relying primarily on self-directed patient interaction.
The rehabilitation protocol emphasizes functional movement patterns, including upper limb coordination, gait-related tasks, and balance. The virtual exercises are designed to align with established neurorehabilitation principles such as repetition, task specificity, and feedback-driven motor learning. Progression within the intervention is structured through graded task difficulty and performance-based adjustments.
Outcome evaluation focuses on quantifying changes in motor performance, cognitive function, functional mobility, and health-related quality of life using validated clinical instruments. Data will also be used to explore the relationship between user engagement characteristics and rehabilitation outcomes.
The study aims to generate evidence on whether integrating collaboration and immersion into virtual rehabilitation environments offers clinically meaningful advantages over conventional non-immersive approaches, thereby informing future design and implementation of technology-assisted neurorehabilitation systems.
- Conditions
- Parkinson Desease
- Being tested
- Collaborative Virtual Environment, Non-Immersive Virtual Reality (NIVR)
- Keywords
- Parkinson Disease, Collaborative Virtual Reality Evinronment, Non Immersive Virtual Reality, Rehabilitation, Motor Control
- 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 EnvironmentOther
Collaborative Virtual Reality Environment (CVE), participants perform exercises within a shared virtual space alongside a therapist, enabling real-time interaction, guidance, and adaptive feedback.
Non-Immersive Virtual Reality (NIVR)Other
Physiotherapy-based rehabilitation delivered through a screen-based virtual environment, involving structured, task-oriented exercises performed with limited therapist interaction
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Non-Immersive Virtual Reality (NIVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)
Secondary outcomes (3)
Falls Efficacy Scale-International (FES-I)
The Falls Efficacy Scale-International (FES-I) is a standardized, self-reported questionnaire used to assess concern about falling during a range of daily activities in individuals with movement disorders, including Parkinson's disease. It evaluates both basic and more demanding physical and social activities, providing a comprehensive measure of fall-related self-efficacy.
The scale consists of 16 items, each scored on a 4-point Likert scale ranging from 1 (not at all concerned) to 4 (very concerned). The total score ranges from 16 to 64, with higher scores indicating greater fear of falling and lower confidence in performing daily activities safely. The FES-I has demonstrated strong reliability, validity, and cross-cultural applicability in clinical and research settings.
Measured: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)
Parkinson's Disease Fatigue Scale (PFS-16)
The Parkinson's Disease Fatigue Scale (PFS-16) is a disease-specific, self-reported instrument used to evaluate the impact and severity of fatigue in individuals with Parkinson's disease. It consists of 16 items focusing on physical fatigue and its effect on daily functioning. Scores are calculated based on patient responses, with higher scores indicating greater fatigue severity. Scale generally uses a 1-5 scoring system, resulting in minimum and maximum average scores of 1.0 (no fatigue) and 5.0 (extreme fatigue), respectively, with minimum 16 and maximum 80 Score.
Measured: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)
Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is a performance-based assessment used to evaluate upper limb function. It measures the ability to perform tasks involving grasp, grip, pinch, and gross arm movement through a series of standardized activities. Each task is scored on an ordinal scale, with higher scores indicating better upper limb function and coordination. The tool assess upper extremity performance, with a total score range from 0 to 57.
Measured: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start27 May 2025
- Primary completion27 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DeseaseStudies 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
- Model description
- Two parallel group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafiz Muddassir Riaz, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523425
- Sponsor's protocol ID
- PhD/RS-4623-A
- Acronym
- CVE vs NIVR
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE EFFECTIVENESS of COLLABORATIVE VIRTUAL ENVIRONMENT and NON-IMMERSIVE VIRTUAL REALITY in the REHABILITATION of PATIENTS With PARKINSON'S DISEASE
- ClinicalTrials.gov ID
- NCT07523425
- Acronym / sponsor ID
- CVE vs NIVR / PhD/RS-4623-A
- Conditions
- Parkinson Desease
- Keywords
- Parkinson Disease, Collaborative Virtual Reality Evinronment, Non Immersive Virtual Reality, Rehabilitation, Motor Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 27 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Apr 2026 (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 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.
Detailed description
This study is designed to investigate the comparative therapeutic value of two distinct virtual reality-based rehabilitation teatement in individuals diagnosed with Parkinson's disease. The focus is on understanding how differences in interaction design, immersion level, and therapist involvement influence clinical outcomes.
The intervention framework is structured around task-oriented, goal-directed activities targeting both motor and cognitive domains commonly affected in Parkinson's disease. The Collaborative Virtual Reality Environment (CVE) incorporates a shared virtual space where the patient and therapist interact synchronously. This setup enables real-time guidance, adaptive feedback, and enhanced engagement through social and therapeutic presence. In contrast, the Non-Immersive Virtual Reality (NIVR) condition delivers similar rehabilitation tasks via a conventional screen-based interface without immersive or collaborative elements, relying primarily on self-directed patient interaction.
The rehabilitation protocol emphasizes functional movement patterns, including upper limb coordination, gait-related tasks, and balance. The virtual exercises are designed to align with established neurorehabilitation principles such as repetition, task specificity, and feedback-driven motor learning. Progression within the intervention is structured through graded task difficulty and performance-based adjustments.
Outcome evaluation focuses on quantifying changes in motor performance, cognitive function, functional mobility, and health-related quality of life using validated clinical instruments. Data will also be used to explore the relationship between user engagement characteristics and rehabilitation outcomes.
The study aims to generate evidence on whether integrating collaboration and immersion into virtual rehabilitation environments offers clinically meaningful advantages over conventional non-immersive approaches, thereby informing future design and implementation of technology-assisted neurorehabilitation systems.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel group
| Arm | Type | Receives |
|---|---|---|
| CVE | Experimental | Other: Collaborative Virtual EnvironmentParticipants 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 |
| NIVR | Other | Other: Non-Immersive Virtual Reality (NIVR)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 |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
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 EnvironmentCollaborative Virtual Reality Environment (CVE), participants perform exercises within a shared virtual space alongside a therapist, enabling real-time interaction, guidance, and adaptive feedback. | Other | CVE |
| Non-Immersive Virtual Reality (NIVR)Physiotherapy-based rehabilitation delivered through a screen-based virtual environment, involving structured, task-oriented exercises performed with limited therapist interaction | Other | NIVR |
Primary outcome
MDS-UPDRS-III
Time frame: From enrollment to the end of treatment at12 weeks
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.
Timed Up and Go (TUG) Test
Time frame: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)
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.
3 secondary outcomes
Falls Efficacy Scale-International (FES-I)
Time frame: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)
Parkinson's Disease Fatigue Scale (PFS-16)
Time frame: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)
Action Research Arm Test (ARAT)
Time frame: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)
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 15 Apr 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Virtual Environment and Non-Immersive Virtual Reality (NIVR) in people with Parkinson Desease, run by Superior University at 1 site 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 7 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Hafiz Muddassir Riaz (+923456627409, muddassir.riaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPDRS-III (time frame: From enrollment to the end of treatment at12 weeks). The study lists 2 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 15 Apr 2026.