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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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