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Completed

NCT Number: NCT07359716

Virtual Reality Verses Conventional Physical Therapy in Parkinson's Disease Patients

Parkinson's disease is a long-term neurological condition that affects movement, balance, and daily activities. People with Parkinson's disease often experience symptoms such as slowness of movement, stiffness, tremors, and difficulty with walking and balance. Physical therapy is commonly used to help improve mobility and quality of life in these patients.

This study aims to compare virtual reality-based physical therapy with conventional physical therapy in individuals diagnosed with Parkinson's disease. Virtual reality therapy uses interactive computer-based exercises, while conventional physical therapy includes traditional exercises provided by a physiotherapist.

Participants will be randomly assigned to one of two groups. One group will receive virtual reality-based physical therapy, and the other group will receive conventional physical therapy. Both groups will follow structured treatment programs over a defined period. Outcomes such as balance, mobility, walking ability, and functional independence will be assessed before and after the intervention.

The results of this study may help determine whether virtual reality-based physical therapy is more effective, equally effective, or less effective than conventional physical therapy for improving movement and daily functioning in people with Parkinson's disease.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shadman Medical Center

Lahore, 54000, Pakistan

About this study

This study is a randomized controlled trial designed to compare the effects of virtual reality-based physical therapy and conventional physical therapy on balance, gait, and fall risk in individuals with Parkinson's disease. The trial will be conducted at Shadman Medical Centre and will follow a parallel-group design. The total duration of the study will be approximately nine months following approval of the research synopsis, which will include participant recruitment, intervention delivery, follow-up assessments, and data analysis.

A total of 62 participants will be enrolled, accounting for an anticipated attrition rate of 20%. The sample size was calculated to detect clinically meaningful differences between groups with 80% statistical power at a 95% confidence level. Participants will be adults aged 45-65 years with a confirmed diagnosis of Parkinson's disease and sufficient cognitive capacity to understand instructions and participate safely in the intervention. Both male and female participants will be included. Individuals with other neurological disorders, recent musculoskeletal trauma or surgery affecting mobility or balance, or conditions that significantly impair safe participation will not be enrolled.

Participants will be recruited using a convenience sampling method and will undergo baseline assessment prior to group allocation. Randomization will be carried out using a lottery method, with allocation occurring after baseline measurements. Outcome assessors and data analysts will remain blinded to group assignment in order to minimize assessment and analysis bias.

Participants will be allocated to either conventional physical therapy or virtual reality-based physical therapy. All interventions will be delivered by licensed physiotherapists who are trained in the standardized study protocol. Both groups will receive three treatment sessions per week for eight weeks, resulting in a total of 24 sessions. Each session will last approximately 45 minutes, including warm-up and cool-down periods. Exercise intensity will be maintained at a moderate level and monitored using the Borg CR10 scale. Participants will continue their stable anti-parkinsonian medication regimen throughout the study period.

Standard safety measures will be implemented for all participants, including pre-session screening of vital signs, continuous therapist supervision, fall-risk monitoring, and use of gait belts when required. Attendance will be documented for each session, and adherence to the intervention will be defined as completion of at least 80% of the prescribed sessions.

Conventional physical therapy will focus on improving balance, gait, strength, and functional mobility through structured exercise sessions. The intervention will include balance training targeting anticipatory, reactive, and sensory integration strategies, gait training with cueing techniques, strengthening of lower-limb and core musculature, and stretching exercises during the cool-down phase. Exercise difficulty and progression will be individualized based on participant performance and tolerance.

Virtual reality-based physical therapy will involve interactive balance and gait training using immersive or semi-immersive virtual environments. Participants will engage in task-oriented activities such as weight shifting, stepping to visual targets, dynamic balance challenges, and gait-related tasks enhanced by real-time visual and auditory feedback. Reactive balance training and dual-task components may be incorporated to simulate functional and environmental demands. Task difficulty will be progressively adjusted according to performance-based criteria, with therapist supervision to ensure safety.

Outcome assessments will be conducted at baseline, mid-intervention, and post-intervention using standardized and validated clinical assessment tools administered by trained assessors in a controlled clinical environment. Assessment procedures will be standardized across all time points to ensure consistency and reliability of measurements.

Ethical approval for the study has been obtained from the Institutional Review Board of the University of Lahore. Written informed consent will be obtained from all participants prior to enrollment. Participant confidentiality will be strictly maintained through anonymization and secure handling of data. Participation will be voluntary, and participants may withdraw from the study at any time without penalty or effect on their standard medical care. All potential risks and benefits will be explained in advance, and participant safety will remain a priority throughout the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with Parkinson's disease. Patients with good cognitive status(MMSE 24 and above) Patients age range from 45- 65 Both male and female population included.

Exclusion criteria

  • Other neurological conditions e.g. stroke, multiple sclerosis. Patients with fracture of lower limb in previous 6 months. Patients with recent major surgery or trauma of peripheries that affect mobility and balance.

Patient with spinal cord injury.

Treatment and study plan

Conventional Physical Therapy

Behavioral

ntervention Description - Conventional Physical Therapy

Conventional physical therapy consists of therapist-guided exercises aimed at improving balance, gait, strength, and functional mobility in individuals with Parkinson's disease. Each session includes a warm-up, structured balance training (anticipatory, reactive, and sensory strategies), overground gait training with cueing techniques, lower-limb and core strengthening exercises, and a cool-down period with stretching and fall-prevention education. Treatment is delivered by licensed physiotherapists three times per week for eight weeks, with exercise difficulty progressively adjusted according to individual performance and tolerance.

Virtual Reality-Based Physical Therapy

Behavioral

Intervention Description - Virtual Reality-Based Physical Therapy

Virtual reality-based physical therapy uses interactive computer-generated environments to provide task-specific balance and gait training with real-time visual and auditory feedback. Participants perform activities such as weight shifting, stepping to virtual targets, obstacle negotiation, and dynamic walking tasks designed to challenge postural control and mobility. Sessions are supervised by trained physiotherapists and delivered three times per week for eight weeks. Task difficulty is progressively increased based on participant performance, with safety measures in place throughout the intervention.

Primary outcomes

  1. Balance and Mobility

    Time frame: Baseline, (2 weeks)then (4 weeks)

    Description: Functional mobility and dynamic balance measured by the Timed Up and Go (TUG) test, which assesses the time it takes a patient to stand up from a chair, walk 3 meters, turn, walk back, and sit down.

Secondary outcomes

  1. Fall Risk

    Time frame: Baseline, (2 weeks)then (4 weeks)

    Assessed using the Fall Efficacy Scale-International (FES-I), which evaluates fear of falling and confidence in performing daily activities without falling.

Sponsors and collaborators

Lead sponsor

Montiha Azeem

Other

Registry information

Acronym: VR-CPT-PD Stud

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jun 26, 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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