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临床试验/NCT04569552
NCT04569552已完成不适用

Urdu Version of the Unified PARKINSON Disease Rating Scale: a Reliability and Validity Study

Riphah International University1 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
215
试验地点
1
主要终点
Unified Parkinson's Disease Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Unified Parkinson's Disease Rating Scale

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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