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

June 11, 2024 updated by: Riphah International University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Fedral
      • Lahore, Fedral, Pakistan, 44000
        • Recruiting
        • Riphah International University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muhammad umar, MS NMPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: participants will receive Virtual Reality intervention with conventional treatment,
Participants will receive 40-minute sessions five days per week for six weeks of Virtual Reality intervention and conventional therapy.
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.
Active Comparator: participants will receive Vestibular Exercises with conventional treatment.
Participants will receive 40-minute sessions five days per week for six weeks of Vestibular Exercises and conventional therapy.
Other: vestibular exercise group
Participants will receive 40-minute sessions five days per week for six weeks of Vestibular Exercises and conventional therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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.
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Zeest hashmi, MSNMPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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