Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:27 AM
Study NCT ID:
NCT07308093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-03
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Not Needed'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinetic Tremors', 'timeFrame': '6 weeks', 'description': "Kinetic Tremors It is going to be measured by: Fahn-Tolosa-Marin tremor rating scale with internal consistency of Cronbach's α = 0.90.\n\nFTMTRS - Kinetic Tremor Section\n\nRate the severity of tremor during each task using the following scale:\n\n1. Writing: \\_\\_\\_\\_\\_\\_\\_\n2. Drawing (Archimedes spiral): \\_\\_\\_\\_\\_\\_\\_\n3. Pouring water: \\_\\_\\_\\_\\_\\_\\_\n4. Drinking from a cup: \\_\\_\\_\\_\\_\\_\\_ • Total Kinetic Tremor Score: \\_\\_\\_\\_\\_\\_\\_/16 (0 = No tremor, 1 = Mild, intermittent, 2 = Moderate, intermittent or mild, continuous, 3 = Marked, intermittent or moderate, continuous, 4 = Severe, continuous)"}, {'measure': 'Bradykinesia', 'timeFrame': '6 weeks', 'description': "It is going to be measured by: MDS-UPDRS Part III with internal consistency of Cronbach's α: 0.90-0.93.\n\nMDS-UPDRS Part III - Bradykinesia Items (3.4-3.6)\n\nRate each movement on a scale from 0 (normal) to 4 (severe):\n\n1. 3.4 L\\&R Finger Tapping: \\_\\_\\_\\_\\_\\_\\_\n2. 3.5 L\\&R Hand Movements (open/close hands): \\_\\_\\_\\_\\_\\_\\_\n3. 3.6 L\\&R Pronation-Supination of Hands: \\_\\_\\_\\_\\_\\_\\_ • Total Bradykinesia Score (3.4-3.6): \\_\\_\\_\\_\\_\\_\\_/24"}, {'measure': 'Proprioception', 'timeFrame': '6 weeks', 'description': "•It is going to be measured by: Fugl Meyer UE Proprioception subscale with internal consistency of Cronbach's α: at 0.94-0.98.\n\nScoring:\n\n0 = Only a few degrees (less than 10° in shoulder)\n\n1. = Decreased\n2. = Normal\n\nShoulder Movement 0 1 2 Flexion (0°-180°) ☐ ☐ ☐ Abduction (0°-90°) ☐ ☐ ☐ External Rotation ☐ ☐ ☐ Internal Rotation ☐ ☐ ☐ Elbow Movement 0 1 2 Flexion ☐ ☐ ☐ Extension ☐ ☐ ☐ Forearm Movement 0 1 2 Pronation ☐ ☐ ☐ Supination ☐ ☐ ☐ Wrist Movement 0 1 2 Flexion ☐ ☐ ☐ Extension ☐ ☐ ☐ Fingers Movement 0 1 2 Flexion ☐ ☐ ☐ Extension ☐ ☐ ☐"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'Sensorimotor Control', 'Virtual Reality Therapy', 'Proprioceptive Neuromuscular Facilitation', 'Upper Limb Rehabilitation', 'Neuroplasticity'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Parkinson's Disease is a chronic neurodegenerative disorder marked by the progressive loss of dopaminergic neurons in the substantia nigra and accumulation of α-synuclein (Lewy bodies).It impacts both motor and non-motor systems, with growing global prevalence-affecting 7-10 million people, mostly men over 60 years-due to increasing life expectancy and demographic shifts.\n\nPD shows motor symptoms like tremors and bradykinesia, along with non-motor issues like depression, REM sleep disorder, and cognitive decline. Diagnosis is often delayed due to subtle early signs like constipation or shoulder pain and atypical cases lacking classical tremors.\n\nVR offers immersive, task-specific therapy that enhances motor learning and neuroplasticity in a safe, engaging environment. By integrating sensory feedback and real-time motion tracking, VR reduces tremors, promotes cortical reorganization (notably in the sensorimotor cortex and cerebellum), and increases rehabilitation motivation through gamified experiences.\n\nPNF is a hands-on therapy using tactile, auditory, and proprioceptive cues to improve coordination, strength, and movement patterns. Especially useful in Parkinson's rehabilitation, PNF targets rigidity, bradykinesia, tremors, and postural instability by reinforcing neuromuscular coordination and improving movement execution in functional, diagonal planes.\n\nSensorimotor control is the dynamic integration of sensory input, motor planning, and execution, which becomes disrupted in PD due to impaired proprioception and feedback loops. Patients rely excessively on visual feedback, making movement effortful, highlighting the need for focused upper limb rehabilitation strategies.", 'detailedDescription': '* Experimental: (VR+ RPT) Participants in this group received Virtual Reality (VR)-based training in addition to Routine Physical Therapy (RPT). The VR intervention was delivered using the Oculus Meta Quest 3 headset and consisted of immersive, goal-directed tasks performed three times per week for six weeks, each session lasting 30 minutes at a moderate intensity (RPE 11-13). VR tasks were designed to target specific motor impairments, including pick-and-place tasks for kinetic tremor reduction, tracing tasks to address bradykinesia, and reaching and grasping tasks to improve proprioception. Participants interacted with five virtual balls in a simulated environment, transferring them from one basket to another under therapist supervision. Alongside VR, participants also underwent Routine Physical Therapy (RPT) three times per week for six weeks, each 40-minute session consisting of a warm-up with diaphragmatic breathing, 30 minutes of stretching and strengthening for the core, hip, knee, back, and elbow extensors, and a cool-down with static stretches for major muscle groups.\n* Control: (PNF+RPT) Participants in this group received Proprioceptive Neuromuscular Facilitation (PNF) therapy in addition to Routine Physical Therapy (RPT). PNF was administered three times per week for six weeks, with each session lasting 30 minutes at a moderate intensity (RPE 11-13). Specific PNF techniques were selected for symptom management: slow reversal for kinetic tremor to improve coordinated agonist-antagonist contractions, rhythmic initiation for bradykinesia to facilitate movement initiation, and tactile input to enhance proprioception and body awareness. PNF was administered under the direct guidance of a physical therapist, with manual contact and graded resistance tailored to individual capacity. Participants also received RPT on the same schedule and with the same structure as described for the experimental group, including warm-up breathing, targeted stretching and strengthening, and cool-down static stretches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Idiopathic Parkinson\'s Disease according to Gelb\'s criteria\n2. Stage II-IV Hoehn \\&Yahr scale\n3. Intact cognition status (MMSE \\> 24)\n4. 50-80 years of age\n\nExclusion Criteria:\n\n1. History of PD surgery\n2. Phobia of virtual gaming systems\n3. Visual anomalies\n4. Cardiovascular problems\n5. Severe dyskinesia or "on-off" fluctuations'}, 'identificationModule': {'nctId': 'NCT07308093', 'acronym': 'VR PNF RPT PD', 'briefTitle': "Comparative Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Lahore University of Biological and Applied Sciences'}, 'officialTitle': "Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation on Upper Limb Sensorimotor Control Among Patients With Parkinson's Disease.", 'orgStudyIdInfo': {'id': 'DPT/ERB/33'}, 'secondaryIdInfos': [{'id': 'U1111-1332-3369', 'type': 'REGISTRY', 'domain': 'Fatima Rehan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'description': 'Participants in this group received Virtual Reality (VR)-based training in addition to Routine Physical Therapy (RPT). The VR intervention was delivered using the Oculus Meta Quest 3 headset and consisted of immersive, goal-directed tasks performed three times per week for six weeks, each session lasting 30 minutes at a moderate intensity (RPE 11-13). VR tasks were designed to target specific motor impairments, including pick-and-place tasks for kinetic tremor reduction, tracing tasks to address bradykinesia, and reaching and grasping tasks to improve proprioception. Participants interacted with five virtual balls in a simulated environment, transferring them from one basket to another under therapist supervision. Alongside VR, participants also underwent Routine Physical Therapy (RPT) three times per week for six weeks, each 40-minute session consisting of a warm-up with diaphragmatic breathing, stretching, strengthening and cool-down.', 'interventionNames': ['Device: artificial intelligence']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Proprioceptive Neuromuscular Facilitation', 'description': 'Participants in this group received Proprioceptive Neuromuscular Facilitation (PNF) therapy in addition to Routine Physical Therapy (RPT). PNF was administered three times per week for six weeks, with each session lasting 30 minutes at a moderate intensity (RPE 11-13). Specific PNF techniques were selected for symptom management: slow reversal for kinetic tremor to improve coordinated agonist-antagonist contractions, rhythmic initiation for bradykinesia to facilitate movement initiation, and tactile input to enhance proprioception and body awareness. PNF was administered under the direct guidance of a physical therapist, with manual contact and graded resistance tailored to individual capacity. Participants also received RPT on the same schedule and with the same structure as described for the experimental group, including warm-up breathing, targeted stretching and strengthening, and cool-down static stretches.', 'interventionNames': ['Other: Intervention 1']}], 'interventions': [{'name': 'Intervention 1', 'type': 'OTHER', 'otherNames': ['Proprioceptive Neuromuscular Facilitation'], 'description': 'Participants in the control group received Proprioceptive Neuromuscular Facilitation (PNF) therapy three times per week for a total duration of six weeks. Each session lasted approximately 30 minutes and was conducted at a moderate intensity, corresponding to an RPE of 11-13 on the Borg scale. For kinetic tremors, the slow reversal technique was applied. For bradykinesia, the rhythmic initiation technique was used. And to enhance proprioception, tactile input was provided through manual contact, resistance, and stretch applied by the therapist at key points of the movement pattern.', 'armGroupLabels': ['Proprioceptive Neuromuscular Facilitation']}, {'name': 'artificial intelligence', 'type': 'DEVICE', 'description': 'Participants in the experimental group underwent Virtual Reality (VR) training three times per week for a total of six weeks. Each session lasted approximately 30 minutes and was conducted at a moderate intensity, defined by the repetition of VR tasks five times per session. The intervention was delivered using the Oculus Meta Quest 2 head-mounted display, providing an immersive and interactive environment under the close supervision of a licensed physical therapist. The central activity involved 2 modules. Ball Shifting Module picking and placing five virtual balls within the simulated environment and transferring them from one basket to another. Cube Navigation Module, in this task, users guide a virtual cube through highlighted cells or routes using deliberate movements, requiring precise hand positioning and controlled movement paths.', 'armGroupLabels': ['Virtual Reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Shoaib Waqas, PhD', 'role': 'CONTACT', 'email': 'shoaib.waqas@ubas.edu.pk'}], 'facility': 'Lahore University of Biological and Applied Sciences', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Shoaib Waqas, PhD', 'role': 'CONTACT', 'email': 'shoaib.waqas@ubas.edu.pk', 'phone': '03024552109'}], 'overallOfficials': [{'name': 'Shoaib Waqas, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lahore University of Biological and Applied Sciences'}, {'name': 'Javeria Younas, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahore College of Physical Therapy'}, {'name': 'Fatima Rehan, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahore College of Physical Therapy'}, {'name': 'Laiba Dhillon, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahore College of Physical Therapy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'June 2026- October 2026', 'ipdSharing': 'YES', 'description': 'After the publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lahore University of Biological and Applied Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dean-0Study Chair', 'investigatorFullName': 'Prof. Dr. Shoaib Waqas', 'investigatorAffiliation': 'Lahore University of Biological and Applied Sciences'}}}}