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CTRI Number  CTRI/2024/05/068212 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship of Verticality with Mobility and fall risk in Individuals with Parkinsons disease 
Scientific Title of Study   Correlation of Vertical Perception with Functional Mobility and Risk of Fall in individuals with 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  Dr Lakshmiprabha Rangarajan 
Designation  Assistant Professor 
Affiliation  P.T. School and Centre Seth GSMC and KEMH 
Address  P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9870487879  
Fax    
Email  laps2204@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lakshmiprabha Rangarajan 
Designation  Assistant Professor 
Affiliation  P.T. School and Centre Seth GSMC and KEMH 
Address  P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9870487879  
Fax    
Email  laps2204@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aishwarya Parab 
Designation  Post graduate Neurophysiotherapy student 
Affiliation  P.T. School and Centre Seth GSMC and KEMH 
Address  P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  8657205556  
Fax    
Email  parab.aishwarya6@gmail.com  
 
Source of Monetary or Material Support  
P.T. School and Centre Seth GSMC and KEMH Seth Dhurmal Bajaj Orthopaedic Centre and Research Institute, Seth GS Medical College and KEM Hospital, Dr Ernest Borges Rd, Parel East, Mumbai Mumbai Mumbai MAHARASHTRA 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [self funded ] 
 
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 Lakhmiprabha Rangarajan  P.T. School and Centre Seth GSMC and KEMH  Room NO 3 Adult neuro OPD P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA 		 9870487879

laps2204@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee 3 of Seth GSMC and KEMH  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 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Individuals with Parkinson’s disease having grade 1 to 3 on Hoehn and Yahr scale
Both genders
Able to follow simple commands
 
 
ExclusionCriteria 
Details  Any vestibular impairment
Any other neurological condition other than Parkinsons disease
Uncorrected visual or auditory impairment
Uncontrolled diabetes and blood pressure
Any other active cardiovascular respiratory disorder
Any psychiatric illness  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
subjective visual vertical test
subjective haptic test
Fall efficacy scale International 		 06 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   11/06/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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, a progressive neurodegenerative condition, is known for motor impairments like tremors, bradykinesia, postural instability, and rigidity. Beyond motor symptoms, it involves less-explored alterations in vertical perception, posing challenges in integrating visual, vestibular, and somatosensory information. This can affect the perception of gravitational verticality, impairing postural responses and increasing fall risk. This study focuses on the overlooked aspect of altered vertical perception in Parkinson’s disease and its impact on functional mobility and fall risk. The study aims to provide insights for improved interventions and assessments. Vertical perception will be assessed using subjective visual vertical tests (SVVT) and subjective haptic tests (SHV), alongside functional tests like the timed up and go test and fall efficacy scale - international. The research aims to reveal correlations among these factors. After obtaining research permission, participants meeting predefined criteria will be recruited. Computer-generated randomization tables will divide participants into three groups with distinct assessment sequences. 1/3rd population undergoes SVVT, SHV, timed up and go test, and fall efficacy scale - international; 1/3rd population follows timed up and go test, fall efficacy scale- international, SVVT, SHV, and 1/3rd population has its order as fall efficacy scale - international, SVVT, SHV, and timed up and go test. This approach ensures a comprehensive understanding of the interplay between vertical perception, functional mobility, and fall risk. Data collected will be analyzed to establish correlations of subjective visual vertical and subjective haptic test with functional mobility and fall risk in individuals with Parkinson’s disease. Pearson’s correlation test will be applied if the data follows a normal distribution, while Spearman’s correlation test will be used if the data is not normally distributed.
 
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