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

Riphah International University

Status: Invitation-only

Conditions: Parkinson Disease

Treatments: Device: virtual reality; Procedure: otago exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06838741

REC/RCR&AHS/24/0251

Details and patient eligibility

About

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.

Full 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:

Enrollment: 74 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• The age group of 50 to 70 years will be included (19).
• Both male and female (20) .
• Patients diagnosed with Parkinson's disease of Hoehn and Yahr stage (1-3)
• Patient should be able to stand 10 minutes at least without assistance.
• Patients should be able to walk with or without assistance.
• Mini mental score should be higher than 24

Exclusion Criteria

• Recent surgery or any fracture.
• Any visual and hearing impairments.
• Any pathology that may impair therapy
• Joint pain or musculoskeletal problem that interfered with therapy (22).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Group A Otago exercises

Experimental group

Description:

It comprises 12 balance exercises and 5 strengthening exercises. The exercises are to be done by participants three times a week. Exercises can be advanced by adding weight or repetitions, contingent on the person's strength and range of motion (weighted ankle cuffs can be utilized and modified during the program).

Treatment:

Procedure: otago exercises

Device: virtual reality

Group B Virtual reality

Experimental group

Description:

Participants in this group will receive virtual realityBegin with 20-30 minutes per session and extend to 30-45 minutes as tolerance and endurance improve throughout the program. Exercise sessions will be done for 3 sessions per week.

Treatment:

Procedure: otago exercises

Device: virtual reality