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NCT Number: NCT06407726

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

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

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Key information

Conditions

Old Age Balance Behavior Ear Diseases Exercise Labyrinth Diseases Motor Activity Otorhinolaryngologic Diseases Vestibular Diseases Vestibular Disorder

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Fedral, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

virtual reality training group

Other

Participants will receive 40-minute sessions five days per week for six weeks of Virtual Reality intervention and conventional therapy.

vestibular exercise group

Other

Participants will receive 40-minute sessions five days per week for six weeks of Vestibular Exercises and conventional therapy.

Primary outcomes

  1. The Dynamic Gait Index (DGI)

    Time frame: 6 months

    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

  2. Berg Balance Scale

    Time frame: 6 months

    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.

  3. Modified Barthel Index

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 9, 2024
Registry last updated
Sep 19, 2024

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.

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