Comparative Effects of Virtual Reality and Vestibular Exercises on Balance Gait in Older Adults

Exercise Clinical Trial

Official title:

Comparative Effects of Virtual Reality and Vestibular Exercises on Balance, Gait, and Activities of Daily Living in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407726
• Other study ID #: REC/RCR & AHS/23/0280
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Zeest hashmi, MS NMPT
• Phone: 03224655851
• Email: zeest.hashmi[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effects of virtual reality and vestibular exercises on balance, gait, and activities of daily living in older adults.

Description:

It will be a randomized clinical trial where non-probability convenience sampling technique will be used. Total 44 participants will be taken aged 60 to 85 years. All Participants will be randomized through lottery method and allocated into two groups. Group A (n=22) participants will receive Virtual Reality intervention with conventional treatment, while Group B (n=22) will receive Vestibular Exercises with conventional treatment. The Berg Balance Scale for balance assessment, Dynamic Gait Index for gait while Time Up and Go Test, and Modified Barthel Index for Activities of Daily Living will be outcome measure tools.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: September 15, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Older adults with or without any assistive device.
• Participants with a Mini-Mental State Examination score greater than 24.
• Participants with a value greater than 10 secs on the Time Up and Go Test.

Exclusion Criteria:

• Severe visual or vestibular impairments (e.g., Meniere's disease, labyrinthitis).
• Significant musculoskeletal impairments (e.g., arthritis, joint contractures).
• Unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease).
• History of epilepsy or seizures.

Related Conditions & MeSH terms

• Balance
• Exercise
• Old Age
• Vestibular Diseases
• Vestibular Disorder

Intervention

Other:
• virtual reality training group
Participants will receive 40-minute sessions five days per week for six weeks of Virtual Reality intervention and conventional therapy.
• vestibular exercise group
Participants will receive 40-minute sessions five days per week for six weeks of Vestibular Exercises and conventional therapy.

Locations

Country	Name	City	State
Pakistan	Riphah International University	Lahore	Fedral

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Lockie RG, Dawes JJ, Kornhauser CL, Holmes RJ. Cross-Sectional and Retrospective Cohort Analysis of the Effects of Age on Flexibility, Strength Endurance, Lower-Body Power, and Aerobic Fitness in Law Enforcement Officers. J Strength Cond Res. 2019 Feb;33(2):451-458. doi: 10.1519/JSC.0000000000001937. — View Citation

Nobrega-Sousa P, Gobbi LTB, Orcioli-Silva D, Conceicao NRD, Beretta VS, Vitorio R. Prefrontal Cortex Activity During Walking: Effects of Aging and Associations With Gait and Executive Function. Neurorehabil Neural Repair. 2020 Oct;34(10):915-924. doi: 10.1177/1545968320953824. Epub 2020 Aug 31. — View Citation

Tornero-Quinones I, Saez-Padilla J, Espina Diaz A, Abad Robles MT, Sierra Robles A. Functional Ability, Frailty and Risk of Falls in the Elderly: Relations with Autonomy in Daily Living. Int J Environ Res Public Health. 2020 Feb 5;17(3):1006. doi: 10.3390/ijerph17031006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Dynamic Gait Index (DGI)	The Dynamic Gait Index (DGI) is a clinical tool assessing balance during walking under different external conditions. It uses a four-point ordinal scale, with a total score of 24. Scores below 19 indicate a higher risk of falls in older adults, while scores above 22 suggest safe ambulation. The DGI has demonstrated validity as a measure of functional mobility and strongly predicts falls	6 months
Primary	Berg Balance Scale	Berg Balance Scale: is a clinical tool assessing static and dynamic balance through 14 functional tasks, each scored from 0 to 4, with a maximum score of 56. Scores below 45 indicate a higher risk of falling. It has demonstrated excellent validity, correlating well with the Timed Up-and-Go test. It also exhibits excellent test-retest reliability, making it a widely accepted tool for measuring balance and mobility.	6 months
Primary	Modified Barthel Index	Modified Barthel Index is widely accepted measure of physical disability, assessing activities of daily living. Scoring ranges from 0 to 20, with lower scores indicating increased disability. The total score reflects the patient's independence in daily activities, with changes of more than two points indicating a probable genuine change. The index has demonstrated validity, with scores between 0.73 and 0.77 compared to a motor ability index for stroke patients.It also exhibits high inter-rater and test-retest reliability,Higher scores indicates maximum recovery	6 months