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临床试验/CTRI/2024/11/076150
CTRI/2024/11/076150尚未招募不适用

Development and Validation of Quality of Life Scale in Parkinson’s Disease

Dr Trupti Vinit Siddapur1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年11月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
37
试验地点
1
主要终点
Quality of life domains

研究概览

简要总结

Parkinson disease (PD) is a most common neurological degenerative, progressive disorder. It is specified by the degeneration of dopaminergic neurons in the substantia nigra and the subsequent depletion of striating dopaminergic pathway.It is indicated by combination of 4 cardinal features of bradykinesia, rigidity, tremor, and postural instability.

Quality of Life (QoL) is a multidimensional construct, which consists of at least three broad domains: physical, mental and social. These are suitable measures as an outcome measure of a new treatment or rehabilitation.Researchers have concluded that the quality of life is affected in patients with Parkinson’s disease.

Thereare some scales which are used worldwide to assess health related quality of life in PD. Most commonly used is PDQ 39 scale. Also, PIMS, SF-36, 15D are the scales used to evaluate QoL in PD. But there are some lacunas seen when we consider Indian population in terms of cultural differences, genetics, environmental variations, etc.  The challenges like Autonomic symptoms, Vocal modulations, Dual tasking, Bradyphrenia, Micrographia are the missing components in most of the available scales. There is lacking literature available on the QOL scales that are developed for only Indian population. The QOL was also found to be influenced by disease stage, severity, duration, and financial security. This research aims to develop a scale on QOL in Parkinson’s disease for  Indian  population by using DELPHI approach.

研究设计

研究类型
Observational

入排标准

年龄范围
35.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with Parkinson’s disease
  • Age- 35 to 80 years
  • Both males and females.

排除标准

  • Patients with any other neurological impairments.
  • Patient with surgical treatment (deep brain stimulation, thalamotomy)
  • Patients with history of upper limb and lower limb deformity (THR/TKR/Stroke), spinal fusion or other orthopaedic surgery in past 6 months.
  • Patients who are on Botox treatment.

结局指标

主要结局

Quality of life domains

时间窗: Item development Nov 2024 till Jan 2025 | Face and content validity | Scale development(till March 2025) | Pilot testing with patients (March 2025- June 2025) | Reliability testing (July 2025 till Nov 2025)

次要结局

  • Comparison of newly developed scale with the gold standard PDQ39(Comparison of newly developed scale with the gold standard PDQ39- In last phase of the study under evaluating reliability (in Nov 2025))

研究者

发起方
Dr Trupti Vinit Siddapur
申办方类型
Other [Self funding]
责任方
Principal Investigator
主要研究者

Dr Trupti Vinit Siddapur

PES Modern College of Physiotherapy, Pune

研究点 (1)

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