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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05405153
Other study ID # RiphahIU Nayab Khurram
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 5, 2022
Est. completion date January 20, 2023

Study information

Verified date March 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 20, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients with any other neurological issue - Patients who undergo brain surgery

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

Ellis 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 8 months
Secondary 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 8 months
Secondary 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.
8 months
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