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NCT Number: NCT07523425

Collaborative vs Non-Immersive VR in Parkinson's Rehabilitation

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.

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Key information

Conditions

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

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Punjab Institute of Neurosciences Lahore

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Collaborative Virtual Environment

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Falls Efficacy Scale-International (FES-I)

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

    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.

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

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

    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.

  3. Action Research Arm Test (ARAT)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hafiz Muddassir Riaz

CONTACT

[email protected]

+923456627409

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

COMPARATIVE EFFECTIVENESS of COLLABORATIVE VIRTUAL ENVIRONMENT and NON-IMMERSIVE VIRTUAL REALITY in the REHABILITATION of PATIENTS With PARKINSON'S DISEASE

Acronym: CVE vs NIVR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 15, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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