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CTRI Number  CTRI/2024/07/071272 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Does motor symptoms affects the quality of life in Parkinsons disease 
Scientific Title of Study   influence of motor symptoms on the quality of life in patients with Parkinsons disease-gender specific 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Daphne Charles M  
Designation  MPT Neurosciences  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy 2nd Floor ,No 1, Ramachandra Nagar Chennai TAMIL NADU 600116 India Chennai TAMIL NADU 600116 India

Chennai
TAMIL NADU
600116
India 
Phone  8667481588  
Fax    
Email  daphnecharles99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Radhika C M 
Designation  MPT NEUROSCIENCES  
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy 2nd Floor ,No 1, Ramachandra Nagar Chennai TAMIL NADU 600116 India Chennai TAMIL NADU 600116 India

Chennai
TAMIL NADU
600116
India 
Phone  9841376961  
Fax    
Email  radhikacm@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  Radhika C M 
Designation  MPT NEUROSCIENCES  
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy 2nd Floor ,No 1, Ramachandra Nagar Chennai TAMIL NADU 600116 India Chennai TAMIL NADU 600116 India

Chennai
TAMIL NADU
600116
India 
Phone  9841376961  
Fax    
Email  radhikacm@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research Institute And Hospitals No 1, Ramachandra Nagar Porur Chennai 600116 
 
Primary Sponsor  
Name  DAPHNE CHARLES 
Address  Sri Ramachandra Institute Of Higher Education And Research Faculty Of Physiotherapy 2nd Floor Chennai TAMIL NADU 
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 Ganeshram P  Athulya assisted living.  Athulya Assisted Living – Pallavaram Tower C, Olympia Grande, No-328, GST Road, Pallavaram, Chennai 600043.
Chennai
TAMIL NADU 		 6385657997

ganeshramphysio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institution Of Ethics Committee  Approved 
Institution Of Ethics Committee  Approved 
Institution Of Ethics Committee  No Objection Certificate 
Sri Ramachandra Ethics Committee For Students Projects  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  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. patients diagnosed with Parkinson’s disease confirmed by medical records and clinical
assessment.
2. Age: Participants aged between 40 and 70 years
3. Stable Medical Condition: Participants should be in a stable medical condition that allows
for participation  
 
ExclusionCriteria 
Details  1. Individuals with cognitive impairment will be excluded from the study since they have
difficulty understanding the instructions given.
2. Patients who did not know reading and writing were also excluded as they could not answer
the questions by themselves.
3. Patients with a history of deep brain stimulation or other neurosurgery operations were
excluded from the study.
4. Patients were excluded if they presented dementia according to the Movement Disorders
Society criteria.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Unified Parkinson Disease Rating Scale  One Time (1 day) 
 
Secondary Outcome  
Outcome  TimePoints 
Parkinson Disease Questionnaire-39  One Time (1 day) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   09/08/2024 
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="0"
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’s disease (PD) is an incurable neurodegenerative disease affecting 572 out of 100,000 adults between 50 and 65 years old. Parkinson`s Disease (PD) can cause various symptoms. Early in the course of the disease, the most obvious symptoms are movement-related, including tremors, rigidity, slowness of movement, and difficulty with walking and gait. Quality of Life (QoL) is a multi-dimensional construct consisting of at least three broad domains: physical, mental, and social. (WHO) defined QOL as “an individual’s perception of their position in life in the context of the culture and value systems in which they live and about their goals, expectations, standards, and concerns. As such, this disorder can significantly impact patients’ quality of life (QoL). Indeed, as with other chronic diseases, several studies have found that PD patients’ QoL is worse than that of healthy controls. There is evidence that regular medication, therapy, social support, education level, and employment status may influence QoL in PD patients. However, it was unclear if the participants in these studies were exclusively treated at a nursing care center. Therefore, we were interested in identifying if the motor clinical features that have well established associations with QoL – for instance, disease duration, depressive symptoms, and motor symptom severity – would still contribute to QoL. There is growing interest in health-related quality of life (HRQOL) as a comprehensive view of the patient’s well-being, guiding concept for the treating clinician, and therapeutic trial outcome measure for patients with Parkinson’s disease. Preliminary evidence suggests that HRQOL in PD varies by sex, disease stage, and proximity to an urban center. To improve the QOL of PD patients, it is important to completely understand how various QOL domains differ in PD patients and healthy controls and initiate therapeutic plans.  
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