StrokeNCT05375578
Urdu Translation of Wayfinding Questionnaire for Stroke Patients
An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Descriptive analytical study to translate WQ in Urdu Language. The WQ is in English Language the name of the author of WQ is Van der Ham Et al and firstly introduced in 2013. The reliability of this English tool is 0.70 to 0.80 it has been translated in various Languages i.e Hungarian, Dutch and Chinese and suffering… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2021to 30 Jul 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stroke
Who may be able to join
- Age group 45-65 years
- Male and Female.
- Both ischemic and hemorrhagic stroke
- Patient may have First or Recurrent Stroke.
- Recovery is > 6 months of First Stroke event
- MMSE score > 25
Who cannot join
- Population suffering from Severe Global Aphasia.
- Population suffering from Severe Mobility Problem.
- Any other neurological disease dementia
- Alzheimer's
- Cognitive Decline before Stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urdu Translation and Cross Cultural Validation of Wayfinding Questionnaire for Stroke Patients
Descriptive analytical study to translate WQ in Urdu Language. The WQ is in English Language the name of the author of WQ is Van der Ham Et al and firstly introduced in 2013. The reliability of this English tool is 0.70 to 0.80 it has been translated in various Languages i.e Hungarian, Dutch and Chinese and suffering from stroke. But it was not translated in Urdu Language. No such study has been previously conducted in Pakistan region which translates the scale and follows the proper cross-cultural adaptation
Read the detailed description
For resolving such problem WQ play pivotal role in accessing navigation problem of stroke patients it is a very reliable tool for accessing navigation issue. The scale consists of 22 items. All the items dated from 01 to 07 in which stroke patients are accessed. The patients who are taken in the study age from 18 to 65 years. As the WQ is a well-developed measurement scale for accessing navigation in stroke patients. It is meaningful to validate its Urdu version. The translation and cultural adaptation process would start after obtaining approval from the developer of the original WQ. This would be done according to bitten guidelines. The purpose will be to gain uniformity in the translation of both the target Language and source Language. This will involve 5 steps which is forward translation, synthesis 1, back translation, synthesis 2 and pallet testing. The second step would be done according to the Beaton guidelines in which psychometric properties will be measured that is internal consistency, test retest reliability, Discriminant validity, Convergent Validity, Content Validity and Factor analysis
- Conditions
- Stroke
- Keywords
- Way finding Questionnaire, Navigation, Cognition.
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Wayfinding Questionnaire
For resolving such problem WQ play pivotal role in accessing navigation problem of stroke patients it is a very reliable tool for accessing navigation issue. The scale consists of 22 items. All the items rated from 1 to 7 in which stroke patients are assessed. The patients who are taken in the study age from 45 to 65 years.
Measured: 8 months
Secondary outcomes (2)
Reliability of translated version of WQ
To determine the reliability of cross-culturally adapted and translated WQ in the patients with stroke.
Reliability or reproducibility reference to a measure to produce the same results when administered at to intervals between different visits of the patients. Thus this will be measured through test re-test reliability
Measured: 8 months
Validity of translated version of WQ
To determine the validity of cross-culturally adapted and translated WQ for stroke patients in Urdu language
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start15 May 2021
- Primary completion15 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehreem Mukhtar, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375578
- Sponsor's protocol ID
- REC/Lhr/22/0207 Suhair Asif
- Status last verified
- Dec 2022
- First submitted
- 28 Apr 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamre C, Fure B, Helbostad JL, Wyller TB, Ihle-Hansen H, Vlachos G, Ursin MH, Tangen GG. Impairments in spatial navigation during walking in patients 70 years or younger with mild stroke. Top Stroke Rehabil. 2020 Dec;27(8):601-609. doi: 10.1080/10749357.2020.1755814. Epub 2020 Apr 21.
PubMed 32316862de Rooij NK, Claessen MHG, van der Ham IJM, Post MWM, Visser-Meily JMA. The Wayfinding Questionnaire: A clinically useful self-report instrument to identify navigation complaints in stroke patients. Neuropsychol Rehabil. 2019 Aug;29(7):1042-1061. doi: 10.1080/09602011.2017.1347098. Epub 2017 Jul 18.
PubMed 28720024
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Translation and Cross Cultural Validation of Wayfinding Questionnaire for Stroke Patients
- ClinicalTrials.gov ID
- NCT05375578
- Acronym / sponsor ID
- REC/Lhr/22/0207 Suhair Asif
- Conditions
- Stroke
- Keywords
- Way finding Questionnaire, Navigation, Cognition.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Descriptive analytical study to translate WQ in Urdu Language. The WQ is in English Language the name of the author of WQ is Van der Ham Et al and firstly introduced in 2013. The reliability of this English tool is 0.70 to 0.80 it has been translated in various Languages i.e Hungarian, Dutch and Chinese and suffering from stroke. But it was not translated in Urdu Language. No such study has been previously conducted in Pakistan region which translates the scale and follows the proper cross-cultural adaptation
Detailed description
For resolving such problem WQ play pivotal role in accessing navigation problem of stroke patients it is a very reliable tool for accessing navigation issue. The scale consists of 22 items. All the items dated from 01 to 07 in which stroke patients are accessed. The patients who are taken in the study age from 18 to 65 years. As the WQ is a well-developed measurement scale for accessing navigation in stroke patients. It is meaningful to validate its Urdu version. The translation and cultural adaptation process would start after obtaining approval from the developer of the original WQ. This would be done according to bitten guidelines. The purpose will be to gain uniformity in the translation of both the target Language and source Language. This will involve 5 steps which is forward translation, synthesis 1, back translation, synthesis 2 and pallet testing. The second step would be done according to the Beaton guidelines in which psychometric properties will be measured that is internal consistency, test retest reliability, Discriminant validity, Convergent Validity, Content Validity and Factor analysis
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke
Key inclusion criteria (6 listed)
- Age group 45-65 years
- Male and Female.
- Both ischemic and hemorrhagic stroke
- Patient may have First or Recurrent Stroke.
- Recovery is > 6 months of First Stroke event
Key exclusion criteria (5 listed)
- Population suffering from Severe Global Aphasia.
- Population suffering from Severe Mobility Problem.
- Any other neurological disease dementia
- Alzheimer's
- Cognitive Decline before Stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wayfinding Questionnaire
Time frame: 8 months
For resolving such problem WQ play pivotal role in accessing navigation problem of stroke patients it is a very reliable tool for accessing navigation issue. The scale consists of 22 items. All the items rated from 1 to 7 in which stroke patients are assessed. The patients who are taken in the study age from 45 to 65 years.
2 secondary outcomes
Reliability of translated version of WQ
Time frame: 8 months
Validity of translated version of WQ
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 32316862Hamre C, Fure B, Helbostad JL, Wyller TB, Ihle-Hansen H, Vlachos G, Ursin MH, Tangen GG. Impairments in spatial navigation during walking in patients 70 years or younger with mild stroke. Top Stroke Rehabil. 2020 Dec;27(8):601-609. doi: 10.1080/10749357.2020.1755814. Epub 2020 Apr 21.
- Background: PubMed 28720024de Rooij NK, Claessen MHG, van der Ham IJM, Post MWM, Visser-Meily JMA. The Wayfinding Questionnaire: A clinically useful self-report instrument to identify navigation complaints in stroke patients. Neuropsychol Rehabil. 2019 Aug;29(7):1042-1061. doi: 10.1080/09602011.2017.1347098. Epub 2017 Jul 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tehreem Mukhtar principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, 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 6 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: finished, as of the sponsor's last update on 12 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wayfinding Questionnaire (time frame: 8 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 NCT05375578, which also lists 2 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 12 Dec 2022.