Collaborative vs Non-Immersive VR in Parkinson's Rehabilitation
ConditionParkinson Desease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorSuperior University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Collaborative Virtual Environment
Other interventionCollaborative 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 interventionPhysiotherapy-based rehabilitation delivered through a screen-based virtual environment, involving structured, task-oriented exercises performed with limited therapist interaction
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: CVEExperimental treatment 1 intervention
Group B: NIVROther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at12 weeks2
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.
Time frame
Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)Secondary outcomes
1
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.
Time frame
Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)2
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.
Time frame
Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)3
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.
Time frame
Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)Sponsors and contacts
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Source ClinicalTrials.gov