Effects of Vestibular Habituation and Ocular Reflex Exercises on Vertigo

January 1, 2025 updated by: Riphah International University

Comparative Effects of Vestibular Habituation and Ocular Reflex Exercises on Gait Stability, Dizziness Severity, and Fear of Fall in Elderly Population With Vertigo

The aim of this study is to determine the comparative effects of vestibular Habituation and ocular reflex exercises on Gait stability, Dizziness severity, and fear of fall in elderly population with vertigo

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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

vestibular habituation exercises focus on helping individual adapt to and reduce symptoms related to vestibular disorder such as improving balance , reducing dizziness and enhance overall functional abilities. ocular reflex exercises focus on improving eye movement control and coordination such as improving visual tracking , stability and Focus. This randomized clinical trial will be conducted at services hospital and Jinnah hospital for a duration of 10 months. The sample size will consist of 50 participants. 25 participants will be assigned to vestibular habituation exercise group and 25 to ocular reflex exercises group. Data will be collected using these assessment tools, including the dynamic gait index for gait stability, the fall efficacy scale for fear of fall, and dizziness handicap inventory for dizziness severity. Pre-intervention assessments will be conducted for all two groups. The effects of the interventions will be measured at baseline ,in the 3rd week ,post intervention, after 6 weeks, and at a 9th week follow up. Data analysis will be performed by using SPSS 26 software

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.
50

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 Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Services Hospital Lahore
      • Lahore, Punjab, Pakistan
        • Rasheed Hospital 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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Both male and female patients
  2. Age 65-75
  3. patient with vestibular disorder for at least 6 months
  4. patient with unspecific dizziness sensation for at least 3 months
  5. Dizziness handicap inventory score > 16 -

Exclusion Criteria:

  1. patient with central nervous system diseases, like stroke, multiple sclerosis, Parkinson's disease.
  2. orthopedic problems that precluded performance of the exercises
  3. systemic diseases with no medication control
  4. if patient were legally blind or had dementia
  5. patient with no history of epilepsy and other neurological diseases -

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: 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: GROUP A Vestibular Habituation Exercises
Group A will receive 24 sessions of vestibular habituation exercises, delivered 4 times weekly for six weeks, each session lasting 30 minutes. Effects will be measured at baseline, in the 3rd week, post-intervention, after six weeks, and at a 9th-week follow-up.
Other: Vestibular Habituation Exercises
The vestibular habituation exercise group follows a structured progression over six weeks. in week 1 participants perform large amplitude, rapid cervical rotations seated, completing 3 sets of five cycles each. By week 2, the exercises increase in complexity , incorporates standing pivots or seated trunk flexion extension. in week 3 the cervical rotations are continued with seated or standing posture. week 4 introduces a busy visual background during the exercise to challenge visual-vestibular integration. In week 5 the exercises are performed standing with the addition complex visual target against a busy background. finally week 6 includes most advance movement including standing pivots 180 degrees and brand-daroff exercises with further visual challenges of near and far targets in busy background. Each exercise session last for 2 minutes and is aimed at progressively enhancing vestibular processing and adaptability.
Experimental: GROUP B Ocular Reflex exercises
Group B will receive ocular reflex exercises. A total of 24 sessions (4x/week for 6 weeks) will be conducted , lasting 50-60 minutes each. The effects will be measured at baseline, in the 3rd week, post intervention, after six weeks, and at a 9th-week follow-up.
Other: Ocular Reflex Excercises
The Ocular reflex exercises focuses on enhancing visual tracking and reflexes through targeted viewing exercises. In week 1, participants perform horizontal and vertical X1 viewing exercises with a near target, holding each position for 1 minute while seated. In week 2 the duration of the X1 exercises is extended to 2 minutes with the near target still in seated position. Week 3 shift to a far target for the X1 exercises and the participants performs them while standing increasing the challenge. By week 4 the exercise incorporate both near and far target in front of a busy background. extending the duration to 2 minutes while standing. In week 5 horizontal and vertical X2 viewing exercises are added with a plain background, while still using near and far targets in front of a busy background . finally week 6 continues the X1 and X2 exercises with near and far targets in a busy background, performed for 2 minutes while standing. This aims to improve visual tracking.

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
Dynamic gait index
Time Frame: 6 weeks
The DGI is used for gait assessment and has 8 items. The scoring of DGI is based on 4 point scale ranging from 0-3 while 0 indicates severe impairment and 3 indicates normal ability. DGI proves to be reliable and valid for older people. Total score for best performance is 24 and low score on DGI indicates greater impairment in functional mobility.
6 weeks
FES-I Fall efficacy scale international
Time Frame: 6 weeks
FES-I scale is used to access fear of fall and is consist of 16 items questionnaire allows participants to rate their fear of falling during specific activities at the rate of four different intensities ranging from "not at all concerned to vary concerned". Higher scores indicates a more significant fear of falling. score range from 16-19 show low concern of falling. Score ranges from 20-27 shows moderate concern and score ranges from 28-64 show high concern of fall to daily Activities.
6 weeks
Dizziness Handicap inventory
Time Frame: 6 weeks
The DHI is used to access dizziness and is consist of 25 items. Each item is answered with No (0) points sometimes (2) points or Yes (4) points. Scoring of DHI ranges from 0 to 100. further divided into physical (28) points , functional (36) points and emotional (36) points. The higher the scores result in perceived handicap. Moreover (DHI) proved to be a reliable instument
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.
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.
  • Study Chair: Hira Jabeen, MS-NMPT, 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 (Estimated)

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.
December 31, 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.
July 31, 2025

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.
August 1, 2025

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).
January 1, 2025

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.
January 1, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
January 1, 2025

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.
January 1, 2025

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/24/0255

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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