Clinical trial NCT06838741: Effects of Virtual Reality and Otago Exercises in Parkinson's Disease Patients.
Official title: Comparison of Effects of Virtual Reality and Otago Exercises on Balance, Gait and Activities of Daily Living in Parkinson's Disease Patients.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Keywords: Activities of daily living
Balance, gait
otago exercises
Parkinsons disease
Virtual reality
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 74
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

Eligibility 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).

Primary outcomes:
measure: Berg Balance scale
timeFrame: 12 weeks
measure: Time Up and Go test
timeFrame: 12 weeks
measure: Unified Parkinson Disease Rating Scale (Activities of Daily Living)
timeFrame: 12 weeks
Secondary outcomes:
measure: mini mental scale
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: General hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu X, Wu X, Hou G, Han P, Jiang L, Guo Q. The Impact of Tai Chi on Motor Function, Balance, and Quality of Life in Parkinson's Disease: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2021 Jan 11;2021:6637612. doi: 10.1155/2021/6637612. eCollection 2021.
citation: Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.
citation: Chua LK, Chung YC, Bellard D, Swan L, Gobreial N, Romano A, Glatt R, Bonaguidi MA, Lee DJ, Jin Y, Liu CY, Fisher BE. Gamified Dual-Task Training for Individuals with Parkinson Disease: An Exploratory Study on Feasibility, Safety, and Efficacy. Int J Environ Res Public Health. 2021 Nov 25;18(23):12384. doi: 10.3390/ijerph182312384.
citation: Balestrino R, Schapira AHV. Parkinson disease. Eur J Neurol. 2020 Jan;27(1):27-42. doi: 10.1111/ene.14108. Epub 2019 Nov 27.
citation: Simon DK, Tanner CM, Brundin P. Parkinson Disease Epidemiology, Pathology, Genetics, and Pathophysiology. Clin Geriatr Med. 2020 Feb;36(1):1-12. doi: 10.1016/j.cger.2019.08.002. Epub 2019 Aug 24.