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CTRI Number  CTRI/2024/05/067192 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Identifying Factors affecting Quality of Life In patients with Parkinsons Disease by using self-made questionnaire 
Scientific Title of Study   Identifying factors affecting Quality of Life In Parkinsons Disease 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shrutika Mate 
Designation  Post Graduate Student 
Affiliation  Dr D Y Patil College of Physiotherapy 
Address  3rd floor, Department Of Neurosciences, Dr D Y Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7972252781  
Fax    
Email  shrutikamate22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preeti Gazbare 
Designation  Professor 
Affiliation  Dr D Y Patil College of Physiotherapy 
Address  3rd floor, Department Of Neurosciences, Dr D Y Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9096116134  
Fax    
Email  preeti.gazbare@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Preeti Gazbare 
Designation  Professor 
Affiliation  Dr D Y Patil College of Physiotherapy 
Address  3rd floor, Department Of Neurosciences, Dr D Y Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9096116134  
Fax    
Email  preeti.gazbare@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune-411018 
 
Primary Sponsor  
Name  Shrutika Mate 
Address  3rd floor, Department Of Neurosciences, Dr D Y Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrutika Mate  Dr. D.Y. Patil College of Physiotherapy  3rd floor, Department Of Neurosciences, Dr D Y Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA 
07972252781

shrutikamate22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of DR. D.Y. Patil College Of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with Parkinson disease by Physician.
2. Patients residing in Maharashtra
3. Willingness to participate
 
 
ExclusionCriteria 
Details  1. Patients with neurological disorders other than Parkinson disease as stroke, Alzheimer disease. (confounding factors) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Self-Made Questionnaire validated by at least 6 subject experts  1. day one (one time study) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response (Others) -  researchers approved by principal investigator

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  researchers who approach principal investigator

  6. For how long will this data be available start date provided 09-11-2024 and end date provided 09-04-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

INTRODUCTION


BACKGROUND OF THE STUDY :

Parkinson’s disease (PD) is a chronic and progressive degenerative neurological disorder characterized by the degeneration of dopamine neurons in the substantia nigra and formation of intracellular Lewy inclusion bodies (Jellinger, 1987). The resulting dopamine deficiency within the basal ganglia leads to a movement disorder characterized by classical parkinsonian motor symptoms. In early PD the full triad of clinical symptoms and signs (rest tremor, bradykinesia, and rigidity) may not yet be manifested.

 

Parkinson’s disease was first medically described as a neurological syndrome by James Parkinson in 1817, although some aspects of Parkinson’s disease were reported in earlier descriptions. For example, Sylvius de la Boë wrote of resting tremor and Sauvages described festination. Much earlier, traditional Indian texts from approximately 1000 BC and ancient Chinese sources also provided descriptions that were reminiscent of Parkinson’s disease. Over 50 years later, Jean-Martin Charcot was more thorough in his descriptions and distinguished bradykinesia as a separate cardinal feature of the illness.

 

Quality of life (QOL) is a broad and multi-dimensional concept that includes physical and mental health, social functioning, and emotional well-being (World Health Organization, 1993). Due to the need to improve quality of life for the elderly, several studies have been conducted to examine factors affecting QOL among older adults. Extant research has yielded several key factors including, demographic factors (e.g., advanced age, marital status, employment, higher education, etc; family relationship and social support, religious affiliation, and depression. More importantly, physical activity (PA), including sport participation, has consistently been positively associated with QOL in older adults. 

 

Parkinson’s disease (PD) is a chronic progressive disorder for which there is no cure. The major motor symptoms of PD are resting tremor, bradykinesia, rigidity, and postural reflex disturbance. Apart from these dopaminergic motor symptoms, non-motor symptoms also develop secondary to serotonergic, noradrenergic, cholinergic, and autonomic nervous system involvement, including major neuropsychiatric symptoms, autonomous disorders, sleep disorders, and sensory symptoms. Non-motor symptoms are seen in about 90% of PD patients in all stages of the disease. However, these symptoms are usually not recognized and are underestimated when planning therapeutic strategies.

 

It affects many aspects of patients’ lives, only some of which can be appreciated by available clinical rating scales. Subjective evaluation of quality of life (QOL) and health status is therefore increasingly recognized to be important in the assessment and treatment of PD patients. Evaluation of QOL has been made possible recently by the development of valid, reliable, and sensitive instruments.

 

 

NEED OF STUDY


§  Prevalence of Parkinson’s Disease in North India is 67.71 per 1 lakh individuals.

§  Studies have been found that Parkinson’s disease affect mainly balance and gait causing problems in their ADL’s. The progressive nature of disease affect Quality Of Study embarking it as a main indicator for assessing health related outcome. 

§  Study stated that there is clear demarcation present in world wide population and Indian population of Parkinson’s disease. Depending upon the ethnicity, Geographical Variation, Indian Parkinson’s disease has variations from other western countries.

§  There are very few studies available on assessing Quality of life in Parkinson’s disease for Indian Scenario.

§  There are cultural differences in western countries and in India like eating habits, way of praying, Ambulation, socio economic status, etc. there is need to assess the problem list of Parkinson’s disease in Maharashtra, Indian scenario.

§  Hence, to identify the same self made questionnaire would help.

 
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