Comparative Effects of Virtual Reality and Proprioceptive... | NCT07308093

ID	Type	Description	Link
U1111-1332-3369	Registry Identifier	Fatima Rehan

Status Module

Description Module

Detailed Description

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.
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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtual Reality	Experimental	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.	Device: artificial intelligence
Proprioceptive Neuromuscular Facilitation	Active Comparator	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.	Other: Intervention 1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intervention 1	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Kinetic Tremors	Kinetic Tremors It is going to be measured by: Fahn-Tolosa-Marin tremor rating scale with internal consistency of Cronbach's α = 0.90. FTMTRS - Kinetic Tremor Section Rate the severity of tremor during each task using the following scale: Writing: _______ Drawing (Archimedes spiral): _______ Pouring water: _______ 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)	6 weeks
Bradykinesia	It is going to be measured by: MDS-UPDRS Part III with internal consistency of Cronbach's α: 0.90-0.93. MDS-UPDRS Part III - Bradykinesia Items (3.4-3.6) Rate each movement on a scale from 0 (normal) to 4 (severe): 3.4 L&R Finger Tapping: _______ 3.5 L&R Hand Movements (open/close hands): _______ 3.6 L&R Pronation-Supination of Hands: _______ • Total Bradykinesia Score (3.4-3.6): _______/24	6 weeks
Proprioception	•It is going to be measured by: Fugl Meyer UE Proprioception subscale with internal consistency of Cronbach's α: at 0.94-0.98. Scoring: 0 = Only a few degrees (less than 10° in shoulder) = Decreased = Normal Shoulder 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 ☐ ☐ ☐	6 weeks

Eligibility Module

Name	Affiliation	Role
Shoaib Waqas, PhD	Lahore University of Biological and Applied Sciences	Study Chair
Javeria Younas, DPT	Lahore College of Physical Therapy	Principal Investigator

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics
D026741	Physical Therapy Modalities
D015444	Exercise
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena