Quality of LifeNCT05449210
Urdu Version of Parkinson's Disease Questionnaire: Reliability and Validity Study
An observational study of Quality of Life, run by Riphah International University at 1 site in Pakistan.
Trial summary
In the study , the researchers will investigate the reliability and validity of Urdu version Parkinson's Disease Questionnaire in Pakistani population having Parkinsonism Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Quality of Life
- How many people
- 195 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2021to 28 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson Disease in advanced age along tremors, rigidity and bradykinesia and postural abnormalities.will be recruited in this study.
Who may be able to join
- Idiopathic Parkinson's Disease
- Minimum age of 40 years
- Minimum level of 5 years of education
- A score equal to or greater than 23 on the Mini-Mental State Examination
- Patient experiencing at least two of the three cardinal symptoms of idiopathic Pairkinson Disease (rigidity, resting tremor, and bradykinesia.)
Who cannot join
- Patients with non-idiopathic Parkinsonian variants
- Patients with a history of drug or alcohol abuse in the last two years
- Patients with unstable medical problems that may place the patient at increased risk or may interfere with the assessment or treatment of Parkinson's
- Neurological operation on the brain within one year prior to study entry
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 3800
About this study
Official title: Reliability and Validity of Urdu Version of Parkinson's Disease Questionnaire in Pakistani Parkinson's Population
In the study , the researchers will investigate the reliability and validity of Urdu version Parkinson's Disease Questionnaire in Pakistani population having Parkinsonism
Read the detailed description
The study is aimed to translate and culturally adapt Parkinson's Disease Questionnaire-39 into Urdu language and to investigate validity and reliability of Parkinson's Disease Questionnaire-39 in Parkinson's diseased patient among Pakistani population.The study will be a cross sectional survey in which non-probability purposive sampling technique will be used to enroll the participants into the study as per criteria.
The results of the study will help to establish an understanding of validity and reliability of Urdu version of Parkinson's Disease Questionnaire-39 with quality of life of Parkinson's Disease patients in Pakistani population having Parkinson's Disease. Reliability of the scale will be checked through internal consistency and test-retest methods. Cronbach's alpha value will be used to analyze internal consistency and for analyzing test-retest reliability an intraclass correlation coefficient with 195 patients will be used
- Conditions
- Quality of Life
- Keywords
- Parkinson's Disease Questionnaire-39, Parkinson's Disease, Reliability, Validity, Urdu Version
- 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
The Parkinson's Disease Questionnaire checks the quality of life of patients suffering from Parkinson Disease
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 May 2021
- Primary completion25 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449210
- Sponsor's protocol ID
- REC-FSD-00237
- Status last verified
- Jan 2023
- First submitted
- 4 Jul 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Urdu Version of Parkinson's Disease Questionnaire in Pakistani Parkinson's Population
- ClinicalTrials.gov ID
- NCT05449210
- Acronym / sponsor ID
- REC-FSD-00237
- Conditions
- Quality of Life
- Keywords
- Parkinson's Disease Questionnaire-39, Parkinson's Disease, Reliability, Validity, Urdu Version
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 8 Jul 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.
In the study , the researchers will investigate the reliability and validity of Urdu version Parkinson's Disease Questionnaire in Pakistani population having Parkinsonism
Detailed description
The study is aimed to translate and culturally adapt Parkinson's Disease Questionnaire-39 into Urdu language and to investigate validity and reliability of Parkinson's Disease Questionnaire-39 in Parkinson's diseased patient among Pakistani population.The study will be a cross sectional survey in which non-probability purposive sampling technique will be used to enroll the participants into the study as per criteria.
The results of the study will help to establish an understanding of validity and reliability of Urdu version of Parkinson's Disease Questionnaire-39 with quality of life of Parkinson's Disease patients in Pakistani population having Parkinson's Disease. Reliability of the scale will be checked through internal consistency and test-retest methods. Cronbach's alpha value will be used to analyze internal consistency and for analyzing test-retest reliability an intraclass correlation coefficient with 195 patients will be used
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson Disease in advanced age along tremors, rigidity and bradykinesia and postural abnormalities.will be recruited in this study.
Key inclusion criteria (5 listed)
- Idiopathic Parkinson's Disease
- Minimum age of 40 years
- Minimum level of 5 years of education
- A score equal to or greater than 23 on the Mini-Mental State Examination
- Patient experiencing at least two of the three cardinal symptoms of idiopathic Pairkinson Disease (rigidity, resting tremor, and bradykinesia.)
Key exclusion criteria (4 listed)
- Patients with non-idiopathic Parkinsonian variants
- Patients with a history of drug or alcohol abuse in the last two years
- Patients with unstable medical problems that may place the patient at increased risk or may interfere with the assessment or treatment of Parkinson's
- Neurological operation on the brain within one year prior to study entry
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
Time frame: 12th Week
The Parkinson's Disease Questionnaire checks the quality of life of patients suffering from Parkinson Disease
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 17 Jan 2023.
- 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.
Muhammad Kashif study chair
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 Quality of Life, 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 5 inclusion and 4 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 17 Jan 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 (time frame: 12th Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2023.