| CTRI Number |
CTRI/2024/11/076150 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Survey |
| Study Design |
Other |
|
Public Title of Study
|
A study on making an assessment tool on Quality of life in Parkinsons disease patients in India |
|
Scientific Title of Study
|
Development and Validation of Quality of Life Scale in Parkinson’s 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 |
Dr Trupti Vinit Siddapur |
| Designation |
Associate Professor |
| Affiliation |
PES Modern College of Physiotherapy, Pune |
| Address |
Building-D Room no- 101
Division- Renuka Gulmohar, Phase 2, Area- Morwadi, Pimpri
City-Pune
Building-D Room no- 101
Division- Renuka Gulmohar, Phase 2, Area- Morwadi, Pimpri
City-Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8806062672 |
| Fax |
|
| Email |
drtrupti.siddapur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zafar Azeem |
| Designation |
Professor |
| Affiliation |
Dr. D.Y.Patil College of Physiotherapy, Pune |
| Address |
Dr. D.Y.Patil College of Physiotherapy, Division- Pimpri, Department- OPD, Room no- VIP suit, ground floor.
Area-Sant Tukaram Nagar, Pimpri, city- Pune
Dr. D.Y.Patil College of Physiotherapy, Division- Pimpri, Department- OPD, Room no- VIP suit, ground floor.
Area-Sant Tukaram Nagar, Pimpri, city- Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9586668118 |
| Fax |
|
| Email |
zafar.azeem@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trupti Vinit Siddapur |
| Designation |
Associate Professor |
| Affiliation |
PES Modern College of Physiotherapy, Pune |
| Address |
Building-D Room no- 101
Division- Renuka Gulmohar, Phase 2, Area- Morwadi, Pimpri
City-Pune
Building-D Room no- 101
Division- Renuka Gulmohar, Phase 2, Area- Morwadi, Pimpri
City-Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8806062672 |
| Fax |
|
| Email |
drtrupti.siddapur@gmail.com |
|
|
Source of Monetary or Material Support
|
| PES Modern College of Physiotherapy, floor- 4th, Division/Department- Neurophysiotherapy Department, Room- Neuro Dept Staffroom, Area-JM road, Shivajinagar, City-Pune. State- Maharashtra, Country- India. Pin code- 411005 |
|
|
Primary Sponsor
|
| Name |
Dr Trupti Vinit Siddapur |
| Address |
Building-D Room no- 101
Division- Renuka Gulmohar, Phase 2, Area- Morwadi, Pimpri
City-Pune |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| Mrs Ragini Datar |
Neuro-Physiotherapy Department, Progressive Education Societys Modern College of Physiotherapy. |
Lokmangal, Jangli Maharaj Road, Shivajinagar, Pune 411005
Pune
MAHARASHTRA |
9922007316
pespune5@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Dr. D.Y. Patil Vidyapeeth Pune |
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 |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Parkinson’s disease
2. Age- 35 to 80 years
3. Both males and females
|
|
| ExclusionCriteria |
| Details |
1. Patients with any other neurological impairments.
2. Patient with surgical treatment (deep brain stimulation, thalamotomy)
3. Patients with history of upper limb and lower limb deformity (THR/TKR/Stroke), spinal fusion or other orthopaedic surgery in past 6 months.
4. Patients who are on Botox treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life domains |
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) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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) |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
11/11/2024 |
| 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="1"
Months="2"
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 - NO
|
|
Brief Summary
|
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. There are 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. |