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

NCT06838741 | Enrolling By Invitation

• 1 other identifier: REC/RCR&AHS/24/0251
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Activities of daily living; Balance, gait; otago exercises; Parkinsons disease; Virtual reality

Outcome Measures

Primary Outcomes (3)

• Berg Balance scale

  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

  12 weeks

• Time Up and Go test

  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).

  12 weeks

• Unified Parkinson Disease Rating Scale (Activities of Daily Living)

  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.

  12 weeks

Secondary Outcomes (1)

• mini mental scale

  10 minutes

Study Arms (2)

Group A Otago exercises

EXPERIMENTAL

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).

Procedure: otago exercises; Device: virtual reality

Group B Virtual reality

EXPERIMENTAL

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.

Procedure: otago exercises; Device: virtual reality

Interventions

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

Group A Otago exercises; Group B Virtual reality

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.

Group A Otago exercises; Group B Virtual reality

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

General hospital

Lahore, Punjab Province, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 33505498 BACKGROUND

• 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.

  PMID: 33848468 BACKGROUND

• 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.

  PMID: 34886114 BACKGROUND

• Balestrino R, Schapira AHV. Parkinson disease. Eur J Neurol. 2020 Jan;27(1):27-42. doi: 10.1111/ene.14108. Epub 2019 Nov 27.

  PMID: 31631455 BACKGROUND

• 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.

  PMID: 31733690 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Sabiha Arshad, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: February 21, 2025
• Study Start: October 1, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)