Parkinson DiseaseNCT05405153
Translation of Parkinson's Disease Questionnaire -8 in Urdu Language
An observational study of Parkinson Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cross cultural analytical study to translate Parkinson's disease questionnaire-8 in Urdu language. Along with the translated version by evaluating its validity and reliability among the patients of Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2022to 20 Jan 2023
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson disease
Who may be able to join
- Age 40-65 years
- Both genders
- Patients with diagnosed Idiopathic Parkinson's disease (IPD) by neurophysician
- Patient able to read Urdu Language. Patients who can participate in community, patients with cognitive issue, Patients with MMSE more than 24 will be included
Who cannot join
- Patients with any other neurological issue
- Patients who undergo brain surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urdu Version of Parkinson's Disease Questionnaire-8. A Cross-cultural Validity and Reliability Study
Cross cultural analytical study to translate Parkinson's disease questionnaire-8 in Urdu language. Along with the translated version by evaluating its validity and reliability among the patients of Parkinson's disease. No such study has been previously conducted in Pakistan which translate this questionnaire in
Urdu and follows the proper cross- culture adaptation. Condition or disease:
Parkinson's disease. Convenient sampling technique would be used
Read the detailed description
Parkinson's Disease Questionnaire-8 (PDQ-8) is the brief version of PDQ-39 formulated to reduce the respondent burden and for convenient use in clinical settings in patients of Parkinson's disease. (PDQ-8) is the patient reported outcome measure constructed by taking one question from each of the eight domains of PDQ-39 (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. PDQ-8 will be translated into Urdu language by Beaton et al guidelines for cross cultural adaptation of tool. The validity and reliability of Urdu version of PDQ-8 will be evaluated by calculating Cronbach's alpha, intra-class correlation coefficient and Pearson/spearman rank correlation co-efficient.
Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage. Factor structure of the PDQ-8 will be extracted using exploratory factor analysis (EFA), utilizing principal component analysis with varimax rotation.
- Conditions
- Parkinson Disease
- Keywords
- PDQ-8, Parkinson's disease, validate .
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's disease questionnaire (PDQ-8)
Parkinson's disease Questionnaire-8 (PDQ-8) is the brief version of PDQ-39 formulated to reduce the respondent burden and for convenient use in clinical settings in patients of Parkinson's disease. (PDQ-8) is the patient reported outcome measure constructed by taking one question from each of the eight domains of PDQ- 39 (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort)
Measured: 8 months
Secondary outcomes (2)
Reliability of translated versions of PDQ-8
To determine the reliability of cross-culturally adapted and translated PDQ-8 in the patients with Parkinson's disease. Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two intervals between different visits of the patient. Thus, the reliability of tool will be assessed by internal consistency and test-retest reliability
Measured: 8 months
Validity of translated versions of PDQ-8
To determine the validity of cross-culturally adapted and translated PDQ-8 in the patients with Parkinson's disease.
Validity is how accurate the results are.
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 posted6 Jun 2022
- Study start5 May 2022
- Primary completion15 Jan 2023
- Study completion20 Jan 2023
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 Parkinson DiseaseStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehreem Mukhtar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405153
- Sponsor's protocol ID
- RiphahIU Nayab Khurram
- Status last verified
- Mar 2023
- First submitted
- 31 May 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhan A, Mohan S, Tarolli C, Schneider RB, Adams JL, Sharma S, Elson MJ, Spear KL, Glidden AM, Little MA, Terzis A, Dorsey ER, Saria S. Using Smartphones and Machine Learning to Quantify Parkinson Disease Severity: The Mobile Parkinson Disease Score. JAMA Neurol. 2018 Jul 1;75(7):876-880. doi: 10.1001/jamaneurol.2018.0809.
PubMed 29582075Ellis TD, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Thackeray A, Thiese MS, Dibble LE. Identifying clinical measures that most accurately reflect the progression of disability in Parkinson disease. Parkinsonism Relat Disord. 2016 Apr;25:65-71. doi: 10.1016/j.parkreldis.2016.02.006. Epub 2016 Feb 2.
PubMed 26876037
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Version of Parkinson's Disease Questionnaire-8. A Cross-cultural Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT05405153
- Acronym / sponsor ID
- RiphahIU Nayab Khurram
- Conditions
- Parkinson Disease
- Keywords
- PDQ-8, Parkinson's disease, validate .
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 6 Jun 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.
Cross cultural analytical study to translate Parkinson's disease questionnaire-8 in Urdu language. Along with the translated version by evaluating its validity and reliability among the patients of Parkinson's disease. No such study has been previously conducted in Pakistan which translate this questionnaire in
Urdu and follows the proper cross- culture adaptation. Condition or disease:
Parkinson's disease. Convenient sampling technique would be used
Detailed description
Parkinson's Disease Questionnaire-8 (PDQ-8) is the brief version of PDQ-39 formulated to reduce the respondent burden and for convenient use in clinical settings in patients of Parkinson's disease. (PDQ-8) is the patient reported outcome measure constructed by taking one question from each of the eight domains of PDQ-39 (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. PDQ-8 will be translated into Urdu language by Beaton et al guidelines for cross cultural adaptation of tool. The validity and reliability of Urdu version of PDQ-8 will be evaluated by calculating Cronbach's alpha, intra-class correlation coefficient and Pearson/spearman rank correlation co-efficient.
Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage. Factor structure of the PDQ-8 will be extracted using exploratory factor analysis (EFA), utilizing principal component analysis with varimax rotation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson disease
Key inclusion criteria (4 listed)
- Age 40-65 years
- Both genders
- Patients with diagnosed Idiopathic Parkinson's disease (IPD) by neurophysician
- Patient able to read Urdu Language. Patients who can participate in community, patients with cognitive issue, Patients with MMSE more than 24 will be included
Key exclusion criteria (2 listed)
- Patients with any other neurological issue
- Patients who undergo brain surgery
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
Parkinson's disease questionnaire (PDQ-8)
Time frame: 8 months
Parkinson's disease Questionnaire-8 (PDQ-8) is the brief version of PDQ-39 formulated to reduce the respondent burden and for convenient use in clinical settings in patients of Parkinson's disease. (PDQ-8) is the patient reported outcome measure constructed by taking one question from each of the eight domains of PDQ- 39 (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort)
2 secondary outcomes
Reliability of translated versions of PDQ-8
Time frame: 8 months
Validity of translated versions of PDQ-8
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 3 Apr 2023.
- Background: PubMed 29582075Zhan A, Mohan S, Tarolli C, Schneider RB, Adams JL, Sharma S, Elson MJ, Spear KL, Glidden AM, Little MA, Terzis A, Dorsey ER, Saria S. Using Smartphones and Machine Learning to Quantify Parkinson Disease Severity: The Mobile Parkinson Disease Score. JAMA Neurol. 2018 Jul 1;75(7):876-880. doi: 10.1001/jamaneurol.2018.0809.
- Background: PubMed 26876037Ellis TD, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Thackeray A, Thiese MS, Dibble LE. Identifying clinical measures that most accurately reflect the progression of disability in Parkinson disease. Parkinsonism Relat Disord. 2016 Apr;25:65-71. doi: 10.1016/j.parkreldis.2016.02.006. Epub 2016 Feb 2.
- 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, MS 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 Parkinson Disease, 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 4 inclusion and 2 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 3 Apr 2023. 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?
Parkinson's disease questionnaire (PDQ-8) (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 NCT05405153, 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 3 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.