| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) - researchers approved by principal investigator
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - researchers who approach principal investigator
- 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.
- 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. |