Effects of Virtual Reality and Otago Exercises in Parkinson's Disease Patients.

Not Applicable

• Conditions: Parkinson Disease

• Registration Number: NCT06838741
• Lead Sponsor: Riphah International University

Brief Summary

Parkinson's disease, the second most common neurological condition, significantly affects motor function, gait, balance, and daily living activities. There is a pressing need for advanced therapies that specifically address these challenges. This study explores the potential benefits of virtual reality and Otago exercises, which may enhance balance and gait by providing sensory feedback crucial for motor learning and relearning. The randomized clinical trial will enroll 74 participants with Parkinson's disease, selected through non-probability convenience sampling. After obtaining synopsis approval, participants will be randomly assigned to one of two groups: Group A will engage in Otago exercises, while Group B will participate in virtual reality sessions. Each treatment session will last for 25 minutes. To evaluate outcomes, various tools will be employed, including the Berg Balance Scale for static balance and the Timed Up and Go test for dynamic balance. The 6-Minute Walk Test will measure gait performance, and the Unified Parkinson Disease Rating Scale will assess activities of daily living. Data normality will be determined using the Kolmogorov-Smirnov test, with subsequent analyses employing either one-way ANOVA or the Kruskal-Wallis test, depending on data distribution, to draw meaningful conclusions regarding treatment efficacy.

Detailed Description

The second most prevalent neurological condition is Parkinson disease. It impairs motor function, gait, balance, and daily living tasks. More advanced therapies that target balance, gait, and activities of daily living are required. Virtual reality helps in cognitive and motor improvement by creating a virtual environment. While otago exercise helps to improve balance and coordination and reduce the risk of falls in Parkinson patients. Virtual reality and otago exercises may help to improve balance and gait by providing sensory feedback that will help in motor learning and relearning. This study will compare the effects of virtual reality and otago exercises on balance, gait, and activities of daily living in patients with Parkinson's disease.

This randomized clinical trial will be carried out in a study setting 10 months after the approval of synopsis. In this study, 74 participants who will meet inclusion criteria through a non-probability convenience sampling technique will be included. Participants will be randomly assigned into 2 groups using online research randomizer software. Group A and Group B participants will receive Otago exercises and virtual reality, respectively. Total treatment time will be 25 minutes. The outcome measuring tools used will be Berg balance scale for static balance and time-up and go to measure dynamic balance; a 6-minute walk test will be used for gait, and Unified Parkinson disease Rating scale for activities of daily living. Kolmogorv-Smirnov test will be used to check normality of data. If data will be normally distributed, a one-way ANOVA will be used, and for non-parametric data, the Kruskal-Wallis test will be used.

Type (Exercises):

Weeks 1-2: Foundation and Familiarization Balance Exercises: Start with basic static balance tasks (e.g., standing on one leg, weight shifting) within a VR environment.

Gait preparation: introduce walking simulations on level ground to familiarize participants with VR-based gait training.

ADL Simulation: Initiate simple ADL tasks in VR, such as reaching for objects or virtual button pressing.

Weeks 3-4: Balance and Coordination Development

* Dynamic Balance: Progress to dynamic balance exercises (e.g., stepping over virtual obstacles, balancing on unstable surfaces in VR).

* Coordination Training: Incorporate dual-task activities where participants perform balance exercises while engaging in cognitive tasks within the VR environment.

* Functional ADLs:

Study Timeline

• Study Start: 2024-10-01
• Study First Submitted: 2025-01-01
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-05-02
• Study Completion: 2025-05-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Berg Balance scale	12 weeks	It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait. A score of 56 indicates functional balance. A score of \< 45 indicates individuals may be at greater risk of falling. A score of ≤49 indicates a risk of falls in individuals with stroke
Time Up and Go test	12 weeks	The patient starts in a seated position. The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling. In Parkinson's, the patient is at high risk of fall if he takes more than 11.5 seconds. High test-retest reliability in patients with Parkinson's Disease (ICC= 0.80).
Unified Parkinson Disease Rating Scale (Activities of Daily Living)	12 weeks	This part consist of 13 items speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and changing clothes, falling, freezing while walking, walking, tremor, sensory complains related to parkinsonism. Score ranging from 0-4, higher the score more will be severity.

Secondary Outcome Measures

Name	Time	Method
mini mental scale	10 minutes	The MMSE includes tasks that measure various cognitive domains such as orientation, memory, attention, calculation, language, and visuospatial abilities. Typically, the exam takes about 10 minutes to administer and consists of a series of questions and simple tasks. Scoring ranges from 0 to 30, with lower scores indicating greater cognitive impairment. It is commonly used in diagnosing and tracking conditions like dementia and Alzheimer's disease

Trial Locations

Locations (1)

General hospital; 🇵🇰 Lahore, Punjab, Pakistan