Translation of Dizziness Handicap Inventory Scale Into Local Languages of Pakistan

March 30, 2022 updated by: Riphah International University
The aim of the present study is to translate the Dizziness Handicap Inventory Scale into Urdu, Pashto, Punjabi, Sindhi and Balochi languages. Along with validation of the translated versions by evaluating their validity and reliability in the people of Pakistan, speaking respective languages and suffering from vertigo and dizziness. No such study has been previously conducted in the Pakistan region which translates the scale and follows the proper cross-culture adaptation.

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.

Detailed Description

Dizziness is one of the most common symptoms of many diseases that not only affects the daily activities of the patient but also negatively alters their jobs and functions. Moreover, mostly the patients having dizziness due to vestibular causes are known to face more problems as compared to the others. A precisely valid and reliable tool has been already designed for the measurement of dizziness while keeping the common complaints of patients in mind. The dizziness handicap inventory (DHI) was introduced in 1990 by Jacobson and Newman. The mentioned questionnaire comprises 25 questions that categorize the dizziness effects in three main areas namely; functional (9 questions, 36 points), emotional (9 questions, 36 points) and physical (7 questions, 28 points). The maximum score is 100 and the minimum is 0. The higher the score, the greater handicap is considered. It has high internal consistency. This tool is widely used in clinical setups to evaluate the condition of the patients and determine the levels to which their quality of life has been affected by dizziness. Additionally, it is very easy to be filled and hardly takes 10 minutes at maximum. The DHI is highly compatible with the international classification of functioning, disability and health tool, which was standardized by WHO in 2001 for measuring the effects of various diseases. The aim of DHI is to evaluate the self-perceived handicap effects of dizziness. The target population are the patients suffering from dizziness due to brain injuries, multiple sclerosis and vestibular disorders.

Since 1990, the DHI has been translated into various languages in order to make its application better. Some examples of the translated languages include Arabic, Brazilian, Spanish, Chinese, Italian, Dutch, French, Norwegian, and German. All of these translated versions have been proved to be very useful, with high validity, reliability and internal consistency.

Thus, The DHI is considered the most beneficial questionnaire for the evaluation of dizziness and unsteadiness, especially related to vestibular rehabilitation. However, this questionnaire does not have any versions that can be utilized in Pakistan such as Urdu, Pushto, Punjabi, Sindhi and Balochi. The purpose of this study is to translate the DHI into Urdu, Pushto, Punjabi, Sindhi and Balochi languages and then evaluating the validity and reliability of these versions in order to make this questionnaire available for research and clinics for the population of Pakistan.

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.
Observational

Enrollment (Anticipated)

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.
1000

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.
  • Name: Sidra Ali Naqvi, MSPT(NMPT*)

Study Locations

  • Pakistan
    • Fedral
      • Islamabad, Fedral, Pakistan, 44000
        • Recruiting
        • Riphah International University
        • Contact:
        • Principal Investigator:
          • Sidra Naqvi, MSNMPT*

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

To meet inclusion criteria participants diagnosed with dizziness and vertigo, clinically stable, and able to read the local language version of the Dizziness Handicap Inventory. Then patient response will be checked on the translated versions

Description

Inclusion Criteria:

  • The patient suffering from vertigo and dizziness for at least 1 month and
  • The ability to walk independently or do their routine tasks will be included in the study.
  • Patients should be capable to complete the questionnaire without any help.

Exclusion Criteria:

  • Patients suffering from blindness,
  • musculoskeletal abnormalities,
  • neurologic disorder, or paralysis in ENT or neurologic evaluation by ENT and
  • neurologist will be excluded from the study.
  • Also, if the patients are unable to cooperate then, they will also be excluded.

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

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
Cross-Cultural Translation of Dizziness Handicap Inventory Scale into the local languages (Punjabi, Pashto, Sindhi, Balochi and Urdu)
Time Frame: 6 months
The Dizziness Handicap Inventory Scale is a first-hand measure of disability for patients with vertigo and dizziness. The mentioned questionnaire comprises 25 questions that categorize the dizziness effects in three main areas namely; functional (9 questions, 36 points), emotional (9 questions, 36 points) and physical (7 questions, 28 points). The maximum score is 100 and the minimum is 0. The higher the score, the greater handicap is considered. It distinguishes itself from other published scales as it has an approach that deals with the concepts of disability and its assessment. Its translation is to be done in the local languages of Pakistan through a rigorous and approved process.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reliability of translated versions
Time Frame: 6 months
To determine the reliability of cross-culturally adapted and the translated Dizziness Handicap Inventory versions in patients with vertigo and dizziness of respective languages۔ Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two or more interval between different visits of the patient. Thus this will be measured through test re-test reliability.
6 months
Validity of translated versions
Time Frame: 6 months
To determine the validity of cross-culturally adapted and the translated Dizziness Handicap Inventory versions in patients with vertigo and dizziness of respective languages۔ Validity is how accurate the results are. Thus this will be measured through various parameters to validate the translated versions as appropriate and applicable.
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

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

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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.
April 1, 2021

Primary Completion (Anticipated)

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 30, 2022

Study Completion (Anticipated)

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 30, 2022

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).
April 8, 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.
April 15, 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.
April 19, 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.
March 31, 2022

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.
March 30, 2022

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.
March 1, 2022

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/00958 Sidra Ali Naqvi

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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