Effects of Balance Training With Gaze Stabilization Exercises in Elderly Patients With Chronic Dizziness

February 10, 2021 updated by: University of Lahore

Effects of Balance Exercise With or Without Gaze Stabilization Exercises on Clinical Outcomes in Elderly Patients With Chronic Dizziness:A Randomized Controlled Trial

Effects of balance training with and without gaze stabilization exercises on clinical outcomes in elderly patients with chronic dizziness: A Randomized Controlled Trial

Study Overview

Status

Status

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

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

In older adults dizziness is a common condition which is associated with repeated falls, fear of falling, depression, anxiety and ultimately loss of independence during activities of daily living. The main objective of this research was to compare the effects of balance training with and without Gaze Stabilization exercises on clinical outcomes in elderly patient with chronic dizziness.Total 64 participants after referral from neurologist were recruited in this study. These participants were randomly assigned into two groups i.e. Group A (Gaze group) and Group B (control group) with 32 participants in each group by sealed envelope method. Gaze group performed balance exercises with gaze stability exercises. Gaze stability exercises are further classified as adaptation and substitution exercises. Adaptation exercises support long term changes with a purpose of decreasing symptoms and maintain postural stability. On the other hand the substitution exercises improving central preprogrammed movement of eyes. Basically gaze stability exercises are defined as habituation exercises which reduce the symptoms of provoking stimulus by continuous exposure to it whereas, group B performed balance exercises with saccade eye exercises.Balance training includes both static and dynamic balance exercises, aimed to improved balance and postural stability with gradually increasing to challenging task. Exercises in balance training included a) single leg balance on firm surface b) heel stand c) marching on firm surface d) toe stand e) tandem walk f) forward and backward walking from normal base of support to weekly progression and training from eyes open to eye close from stable to unstable surface. Berg Balance Scale, Disability Handicapped inventory and Activity Specific Balance Confidence Scale were used to measure outcome variables.

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 (Actual)

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.
64

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 Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 5400
        • Univeristy Of Lahore

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

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Geriatric population
  • Both Gender
  • H/O chronic dizziness with normal vestibular function
  • H/O age related balance impairment
  • H/O impaired balance having a Berg Balance Scale (BBS) score between 35-45
  • Participant have sufficient cognitive and communication skills

Exclusion Criteria:

  • H/O insufficient communication skills to follow instructions
  • H/O impaired vestibular function
  • H/O Visual impairment
  • H/O Severe hearing loss
  • H/O mental disorder that could restrains the ability to concentrate during therapy
  • H/O Other systematic diseases
  • Any history of marked musculoskeletal impairment, lower limb injury, surgery other than age related changes and balance disorder due to other neurological conditions like Parkinsonism, stroke, multiple sclerosis etc. were excluded from the study

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Gaze Group
Participants performed balance training with gaze stabilization exercises
Other: Gaze Stabilization Exercises
Gaze group performed balance exercises with gaze stability exercise.Gaze stability exercises included two types of exercises vestibular adaptation and substitution exercises. In Adaptation exercises individual need to fixate on a visual target during horizontal and vertical head movement with a purpose of increasing gaze stability and a long term gain to vestibular system. Subsitution exercises are planned to use other eye movement stratigies to substitute vestibular function and sustained visual fixation. During Substitution exercises individual need to perfomed eye head movement between target with a purpose of clear sighting during these tasks. Balance exercises consist of both static and dynamic balance exercises with weekly progression making balance exercises more challenging.
Other: Control Group
Participants performed balance training with saccade eye exercises
Other: Balance Training
Participants performed balance training with saccade eye exercises.balance exercises included both static and dynamic balance exercises with a purpose of increasing mobility and stability of a posture by weekly progression. These exercises included standing on firm and foam surface with eyes open or close, heel stand, toe stand, marching on firm surface, forward and backward walking with normal base of support with weekly progression. Each task was performed for 5 repetitions with weekly progression in each task.

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
Berg Balance Scale
Time Frame: 6 Weeks
Balance was measured using Berg Balance Scale
6 Weeks
Disability Handicapped Inventory
Time Frame: 6 Weeks
Precieved Disability was measured using Disability Handicapped Invertory
6 Weeks
Activity Specific Balance Confidence
Time Frame: 6 Weeks
Risk of Fall Prevention was measured using Activity Specific Balance Confidence
6 Weeks

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.
University of Lahore

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: Syeda Nida Fatima, University of Lahore

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.
March 5, 2020

Primary Completion (Actual)

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.
December 5, 2020

Study Completion (Actual)

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.
December 8, 2020

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).
February 10, 2021

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.
February 10, 2021

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.
February 11, 2021

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.
February 11, 2021

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.
February 10, 2021

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.
February 1, 2021

More Information

Terms related to this study

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.
  • IRB-UOL-FAHS/718-XII/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Results of study

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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