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AzTrials

VertigoNCT04849078

Translation of Dizziness Handicap Inventory Scale Into Local Languages of Pakistan

An observational study of Vertigo and Dizziness, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vertigo, Dizziness
How many people
1,000 participants
Where
1 sitePakistan
Study dates
1 Apr 2021to 30 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Imran Amjad, PhD contact

03324390125

imran.amjad@riphah.edu.pk

Sidra Ali Naqvi, MSPT(NMPT*) contact

Pakistan1 site, 1 recruiting

  • Riphah International University

    Islamabad, Fedral, 44000

    Imran Amjad, PhD, +92 332 4390125, imran.amjad@riphah.edu.pk

    Sidra Naqvi, MSNMPT*

    Recruiting

Other trials in Pakistan

About this study

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.

Read the 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.

Conditions
Vertigo, Dizziness
Keywords
vertigo, dizziness, dizziness handicap inventory
Medical subject headings
Vertigo, Dizziness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cross-Cultural Translation of Dizziness Handicap Inventory Scale into the local languages (Punjabi, Pashto, Sindhi, Balochi and Urdu)

    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.

    Measured: 6 months

Secondary outcomes (2)

  1. Reliability of translated versions

    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.

    Measured: 6 months

  2. Validity of translated versions

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start1 Apr 2021
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04849078
Sponsor's protocol ID
REC/00958 Sidra Ali Naqvi
Status last verified
Mar 2022
First submitted
8 Apr 2021
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.

    PubMed 2317323

  • Poon DM, Chow LC, Au DK, Hui Y, Leung MC. Translation of the dizziness handicap inventory into Chinese, validation of it, and evaluation of the quality of life of patients with chronic dizziness. Ann Otol Rhinol Laryngol. 2004 Dec;113(12):1006-11. doi: 10.1177/000348940411301212.

    PubMed 15633905

  • Nola G, Mostardini C, Salvi C, Ercolani AP, Ralli G. Validity of Italian adaptation of the Dizziness Handicap Inventory (DHI) and evaluation of the quality of life in patients with acute dizziness. Acta Otorhinolaryngol Ital. 2010 Aug;30(4):190.

    PubMed 21253284

  • Kurre A, Bastiaenen CH, van Gool CJ, Gloor-Juzi T, de Bruin ED, Straumann D. Exploratory factor analysis of the Dizziness Handicap Inventory (German version). BMC Ear Nose Throat Disord. 2010 Mar 15;10:3. doi: 10.1186/1472-6815-10-3.

    PubMed 20230621

  • Alsanosi AA. Adaptation of the dizziness handicap inventory for use in the Arab population. Neurosciences (Riyadh). 2012 Apr;17(2):139-44.

    PubMed 22465888

  • Castro AS, Gazzola JM, Natour J, Gananca FF. [Brazilian version of the dizziness handicap inventory]. Pro Fono. 2007 Jan-Apr;19(1):97-104. doi: 10.1590/s0104-56872007000100011. Portuguese.

    PubMed 17461352

  • Perez N, Garmendia I, Martin E, Garcia-Tapia R. [Cultural adaptation of 2 questionnaires for health measurement in patients with vertigo]. Acta Otorrinolaringol Esp. 2000 Oct;51(7):572-80. Spanish.

    PubMed 11270034

  • Vereeck L, Truijen S, Wuyts F, Van de Heyning PH. Test-retest reliability of the Dutch version of the Dizziness Handicap Inventory. B-ENT. 2006;2(2):75-80.

    PubMed 16910291

  • Nyabenda A, Briart C, Deggouj N, Gersdorff M. [Normative study and reliability of French version of the dizziness handicap inventory]. Ann Readapt Med Phys. 2004 Apr;47(3):105-13. doi: 10.1016/j.annrmp.2003.11.002. French.

    PubMed 15059673

  • Tamber AL, Wilhelmsen KT, Strand LI. Measurement properties of the Dizziness Handicap Inventory by cross-sectional and longitudinal designs. Health Qual Life Outcomes. 2009 Dec 21;7:101. doi: 10.1186/1477-7525-7-101.

    PubMed 20025754

  • Kurre A, van Gool CJ, Bastiaenen CH, Gloor-Juzi T, Straumann D, de Bruin ED. Translation, cross-cultural adaptation and reliability of the german version of the dizziness handicap inventory. Otol Neurotol. 2009 Apr;30(3):359-67. doi: 10.1097/MAO.0b013e3181977e09.

    PubMed 19225437

Questions about this trial

What is this clinical trial studying?

An observational study of Vertigo and Dizziness, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cross-Cultural Translation of Dizziness Handicap Inventory Scale into the local languages (Punjabi, Pashto, Sindhi, Balochi and Urdu) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04849078, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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