Parkinson DiseaseNCT04569552
Urdu Version of the Unified PARKINSON Disease Rating Scale
An observational study of Parkinson Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
The Unified Parkinson's Disease Rating Scale version 3.0 (UPDRS), published in 1987, was developed to provide a comprehensive instrument for the evaluation of impairment and disability related to PD. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 215 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2020to 20 Jan 2021
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects were at least 50 years of age and were at Hoehn and Yahr stage 3.0 or less. The diagnosis of PD was made by a movement disorders specialist based on the presence of at least two of the three cardinal signs of PD (resting tremor, rigidity, or bradykinesia) without a known or suspected alternative cause of parkinsonism.
Who may be able to join
- Idiopathic Parkinson's disease.
- Modified Hoehn and Yahr Scale(H\&Y stages I to III),
- Independent in transfers
- A score equal to or greater than 24 on the Mini-Mental State Examination (MMSE), and
- Previous lack of participation in balance or motor training.
Who cannot join
- History of any neurological conditions such as stroke, multiple sclerosis, epilepsy other than Parkinson's disease,
- History of orthopedic issues such as pain, fracture, or lower limb pathology,
- History of visual abnormalities,
- History of any chronic or cardiovascular pathology that can interfere with the transfer procedure or can affect the training sessions,
- The participants having severe dyskinesia or "on-off" phases,
- Previous history of surgery for PD,
- History of virtual games used for treatment in the past three months, and
- Virtual game phobia.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University Institute of Physical Therapy, The University of Lahore
Lahore, Punjab Province, 4200
About this study
Official title: Urdu Version of the Unified PARKINSON Disease Rating Scale: a Reliability and Validity Study
The Unified Parkinson's Disease Rating Scale version 3.0 (UPDRS), published in 1987, was developed to provide a comprehensive instrument for the evaluation of impairment and disability related to PD. The primary objectives of this research were to translate, validate and generate data on the UPDRS for using among Urdu speaking residents of Pakistan. UPDRS questionnaire will be first translated into Urdu and then apply on Parkinson's Disease patients to check the validity and reliability of this scale . Instrument will be first translated from English to Urdu by two experts. Both these experts were fluent in English and Urdu language.
One expert belongs to allied health care profession and other expert will be junior life scientist. The third expert compares the initial to Urdu translation and formulated the first draft of UPDRS. Content validity of UPDRS Questionnaire was established by committee method. 10 experts from physical therapy field rate the all items of the UPDRS on content validity index . They rate each item of UPDRS Questionnaire for its relevance, clarity, simplicity, and ambiguity on four point ordinal likert scale. Data will be analyzed using SPSS v 25. Intra class correlation coefficient, chronbach alpha and factor analysis will be used to analyses the data.
Read the detailed description
Parkinson's disease (PD) is a complex disorder with a combination of characteristic motor signs and non-motor symptoms. The natural course of PD is modified by the effect of treatments, and over time, these treatments can also be associated with both motor and non-motor complications. At present, there is no biomarker or other gold standard index to determine the severity of PD as a whole. Therefore, measurement of the different aspects of PD and their severities relies on clinically based rating scales.
The Unified Parkinson's Disease Rating Scale version 3.0 (UPDRS), published in 1987, was developed to provide a comprehensive instrument for the evaluation of impairment and disability related to PD. Further, the scale attempted to utilize the most clinically relevant aspects of several earlier scales that were already familiar to clinicians and researchers, though poorly validated clinimetrically. The development of this "unified" scale was aimed to provide a single scale so that outcomes among different clinical trials could be directly compared. For two decades, the UPDRS was the most used scale for assessment of PD patients and became the reference scale for development of other measures and for the United States and European regulatory agencies.
In 2002, the Movement Disorder Society sponsored Task Force for Rating Scales in PD carried out a review and critique of the UPDRS. Several weaknesses, including ambiguities in wording, the absence of uniform instructions for raters, some metric flaws, and the lack of assessments for many important non-motor symptoms were evident. Therefore, a modified UPDRS, named the Movement Disorder Society-UPDRS (MDS-UPDRS), was proposed to overcome the identified shortcomings. In 2008, the official MDS-UPDRS English version was published along with satisfactory clinimetric results on its performance in a series of over 800 native English-speaking patients and raters. As a result, the MDS-UPDRS has been proposed as the official benchmark scale for PD.
Given the content and structure of the MDS-UPDRS, with inclusion of symptoms impossible to assess objectively (e.g., fatigue, pain, dizziness), a questionnaire for self-evaluation, and a wide body of instructions for raters, the scale has to be cross-culturally adapted and validated. A detailed plan for obtaining equivalent and locally validated non-English versions of the MDS-UPDRS was established by the Steering Committee of the Movement Disorder Society Task Force and Spanish, Italian and Estonian official versions are now available.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Validity, Reliability, UPDRS
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale
UPDRS is a subjective tool with widespread use in the clinical settings used for the Parkinson disease (PD). This scale includes 31 items divided into three sub-scales; sub-scale-I includes scoring on mentation, behavior and mood, sub-scale-II includes scoring on activities of daily living and sub-scale-III assesses motor system. This test predicts the performance of physical performance of the adult population affected with the neurological impairments and the performance comes out to be really well when used in combination with Berg Balance Scale. The test is authenticated to be able to detect minimal changes in performance over time and to be used across variety of rehabilitation interventions. A possible maximum of 199 points can be scored in this scale. 199 score refers to complete disability and 0 refers to absence of disability
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Oct 2020
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, PhD*, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569552
- Sponsor's protocol ID
- REC-FSD-00227 Muhammad Kashif
- Status last verified
- Mar 2021
- First submitted
- 24 Sep 2020
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Siderowf A, McDermott M, Kieburtz K, Blindauer K, Plumb S, Shoulson I; Parkinson Study Group. Test-retest reliability of the unified Parkinson's disease rating scale in patients with early Parkinson's disease: results from a multicenter clinical trial. Mov Disord. 2002 Jul;17(4):758-63. doi: 10.1002/mds.10011.
PubMed 12210871Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. The Unified Parkinson's Disease Rating Scale (UPDRS): status and recommendations. Mov Disord. 2003 Jul;18(7):738-50. doi: 10.1002/mds.10473.
PubMed 12815652Abdolahi A, Scoglio N, Killoran A, Dorsey ER, Biglan KM. Potential reliability and validity of a modified version of the Unified Parkinson's Disease Rating Scale that could be administered remotely. Parkinsonism Relat Disord. 2013 Feb;19(2):218-21. doi: 10.1016/j.parkreldis.2012.10.008. Epub 2012 Oct 25.
PubMed 23102808Post B, Merkus MP, de Bie RM, de Haan RJ, Speelman JD. Unified Parkinson's disease rating scale motor examination: are ratings of nurses, residents in neurology, and movement disorders specialists interchangeable? Mov Disord. 2005 Dec;20(12):1577-84. doi: 10.1002/mds.20640.
PubMed 16116612van Hilten JJ, van der Zwan AD, Zwinderman AH, Roos RA. Rating impairment and disability in Parkinson's disease: evaluation of the Unified Parkinson's Disease Rating Scale. Mov Disord. 1994 Jan;9(1):84-8. doi: 10.1002/mds.870090113.
PubMed 8139609
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Version of the Unified PARKINSON Disease Rating Scale: a Reliability and Validity Study
- ClinicalTrials.gov ID
- NCT04569552
- Acronym / sponsor ID
- REC-FSD-00227 Muhammad Kashif
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Validity, Reliability, UPDRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Collaborators
- University of Lahore
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 30 Sep 2020 (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.
The Unified Parkinson's Disease Rating Scale version 3.0 (UPDRS), published in 1987, was developed to provide a comprehensive instrument for the evaluation of impairment and disability related to PD. The primary objectives of this research were to translate, validate and generate data on the UPDRS for using among Urdu speaking residents of Pakistan. UPDRS questionnaire will be first translated into Urdu and then apply on Parkinson's Disease patients to check the validity and reliability of this scale . Instrument will be first translated from English to Urdu by two experts. Both these experts were fluent in English and Urdu language.
One expert belongs to allied health care profession and other expert will be junior life scientist. The third expert compares the initial to Urdu translation and formulated the first draft of UPDRS. Content validity of UPDRS Questionnaire was established by committee method. 10 experts from physical therapy field rate the all items of the UPDRS on content validity index . They rate each item of UPDRS Questionnaire for its relevance, clarity, simplicity, and ambiguity on four point ordinal likert scale. Data will be analyzed using SPSS v 25. Intra class correlation coefficient, chronbach alpha and factor analysis will be used to analyses the data.
Detailed description
Parkinson's disease (PD) is a complex disorder with a combination of characteristic motor signs and non-motor symptoms. The natural course of PD is modified by the effect of treatments, and over time, these treatments can also be associated with both motor and non-motor complications. At present, there is no biomarker or other gold standard index to determine the severity of PD as a whole. Therefore, measurement of the different aspects of PD and their severities relies on clinically based rating scales.
The Unified Parkinson's Disease Rating Scale version 3.0 (UPDRS), published in 1987, was developed to provide a comprehensive instrument for the evaluation of impairment and disability related to PD. Further, the scale attempted to utilize the most clinically relevant aspects of several earlier scales that were already familiar to clinicians and researchers, though poorly validated clinimetrically. The development of this "unified" scale was aimed to provide a single scale so that outcomes among different clinical trials could be directly compared. For two decades, the UPDRS was the most used scale for assessment of PD patients and became the reference scale for development of other measures and for the United States and European regulatory agencies.
In 2002, the Movement Disorder Society sponsored Task Force for Rating Scales in PD carried out a review and critique of the UPDRS. Several weaknesses, including ambiguities in wording, the absence of uniform instructions for raters, some metric flaws, and the lack of assessments for many important non-motor symptoms were evident. Therefore, a modified UPDRS, named the Movement Disorder Society-UPDRS (MDS-UPDRS), was proposed to overcome the identified shortcomings. In 2008, the official MDS-UPDRS English version was published along with satisfactory clinimetric results on its performance in a series of over 800 native English-speaking patients and raters. As a result, the MDS-UPDRS has been proposed as the official benchmark scale for PD.
Given the content and structure of the MDS-UPDRS, with inclusion of symptoms impossible to assess objectively (e.g., fatigue, pain, dizziness), a questionnaire for self-evaluation, and a wide body of instructions for raters, the scale has to be cross-culturally adapted and validated. A detailed plan for obtaining equivalent and locally validated non-English versions of the MDS-UPDRS was established by the Steering Committee of the Movement Disorder Society Task Force and Spanish, Italian and Estonian official versions are now available.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were at least 50 years of age and were at Hoehn and Yahr stage 3.0 or less. The diagnosis of PD was made by a movement disorders specialist based on the presence of at least two of the three cardinal signs of PD (resting tremor, rigidity, or bradykinesia) without a known or suspected alternative cause of parkinsonism.
Key inclusion criteria (5 listed)
- Idiopathic Parkinson's disease.
- Modified Hoehn and Yahr Scale(H\&Y stages I to III),
- Independent in transfers
- A score equal to or greater than 24 on the Mini-Mental State Examination (MMSE), and
- Previous lack of participation in balance or motor training.
Key exclusion criteria (8 listed)
- History of any neurological conditions such as stroke, multiple sclerosis, epilepsy other than Parkinson's disease,
- History of orthopedic issues such as pain, fracture, or lower limb pathology,
- History of visual abnormalities,
- History of any chronic or cardiovascular pathology that can interfere with the transfer procedure or can affect the training sessions,
- The participants having severe dyskinesia or "on-off" phases,
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
Unified Parkinson's Disease Rating Scale
Time frame: 1 Week
UPDRS is a subjective tool with widespread use in the clinical settings used for the Parkinson disease (PD). This scale includes 31 items divided into three sub-scales; sub-scale-I includes scoring on mentation, behavior and mood, sub-scale-II includes scoring on activities of daily living and sub-scale-III assesses motor system. This test predicts the performance of physical performance of the adult population affected with the neurological impairments and the performance comes out to be really well when used in combination with Berg Balance Scale. The test is authenticated to be able to detect minimal changes in performance over time and to be used across variety of rehabilitation interventions. A possible maximum of 199 points can be scored in this scale. 199 score refers to complete disability and 0 refers to absence of disability
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 29 Mar 2021.
- Background: PubMed 12210871Siderowf A, McDermott M, Kieburtz K, Blindauer K, Plumb S, Shoulson I; Parkinson Study Group. Test-retest reliability of the unified Parkinson's disease rating scale in patients with early Parkinson's disease: results from a multicenter clinical trial. Mov Disord. 2002 Jul;17(4):758-63. doi: 10.1002/mds.10011.
- Background: PubMed 12815652Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. The Unified Parkinson's Disease Rating Scale (UPDRS): status and recommendations. Mov Disord. 2003 Jul;18(7):738-50. doi: 10.1002/mds.10473.
- Background: PubMed 23102808Abdolahi A, Scoglio N, Killoran A, Dorsey ER, Biglan KM. Potential reliability and validity of a modified version of the Unified Parkinson's Disease Rating Scale that could be administered remotely. Parkinsonism Relat Disord. 2013 Feb;19(2):218-21. doi: 10.1016/j.parkreldis.2012.10.008. Epub 2012 Oct 25.
- Background: PubMed 16116612Post B, Merkus MP, de Bie RM, de Haan RJ, Speelman JD. Unified Parkinson's disease rating scale motor examination: are ratings of nurses, residents in neurology, and movement disorders specialists interchangeable? Mov Disord. 2005 Dec;20(12):1577-84. doi: 10.1002/mds.20640.
- Background: PubMed 8139609van Hilten JJ, van der Zwan AD, Zwinderman AH, Roos RA. Rating impairment and disability in Parkinson's disease: evaluation of the Unified Parkinson's Disease Rating Scale. Mov Disord. 1994 Jan;9(1):84-8. doi: 10.1002/mds.870090113.
- 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, PhD* principal investigator
University of Lahore
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 5 inclusion and 8 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 29 Mar 2021. 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?
Unified Parkinson's Disease Rating Scale (time frame: 1 Week). 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 NCT04569552, which also lists 5 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 29 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.