Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06838741

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General hospital

Lahore, Punjab Province, Pakistan

About this study

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:

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

otago exercises

Procedure

A walking program is given to participants, with the goal of including two 30-minute walking sessions each week (which can be divided into shorter segments, like three ten-minute blocks).

Exercises Start exercises with 10 repetition maximum STRENGTH Knee extensor Hold for 3-5 seconds Knee flexor Hold for 3-5 seconds Hip adductor Hold for 3-5 seconds Ankle planter-flexion Calf raises Ankle dorsiflexion Toe raise BALANCE Knee bends Backwards walking Upto 30 minutes Walking and turning around 5-10 minutes Sideways walking Tandem stance Heel to toe stand Tandem walk One leg stand Heel walking Toe walk Heel toe walking backwards Sit to stand Stair walking

Virtual reality

Device

Begin 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.

Primary outcomes

  1. Berg Balance scale

    Time frame: 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

  2. Time Up and Go test

    Time frame: 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).

  3. Unified Parkinson Disease Rating Scale (Activities of Daily Living)

    Time frame: 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 outcomes

  1. mini mental scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparison of Effects of Virtual Reality and Otago Exercises on Balance, Gait and Activities of Daily Living in Parkinson's Disease Patients.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.