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CTRI Number  CTRI/2022/10/046894 [Registered on: 28/10/2022] Trial Registered Prospectively
Last Modified On: 26/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   EVALUATION OF THE RISK OF FALLS IN THE ELDERLY POPULATION ABOVE 60 YEARS OF AGE 
Scientific Title of Study   EVALUATION OF THE RISK OF FALLS IN OLDER ADULTS IN URBAN AND RURAL POPULATION OF MAHARASHTRA: A PROSPECTIVE COHORT STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepika Metange 
Designation  Associate Professor 
Affiliation  TERNA PHYSIOTHERAPY COLLEGE, NAVI MUMBAI 
Address  Terna Physiotherapy College, Terna Medical College campus, 3rd floor, Near Sarsole Bus Depot, Sector-12, Nerul West-400706 Navi Mumbai, Maharashtra

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone    
Fax    
Email  deepikapuri12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Saraswati Iyer 
Designation  Professor and HOD 
Affiliation  Seth GS Medical College and KEM Hospital, Dept of Physiotherapy  
Address  Seth GS Medical College and KEM Hospital, Department of Physiotherapy, 1st floor, Orthopaedic building campus, Parel, Mumbai, Maharashtra

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  9sarasiyer@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepika Metange 
Designation  Associate Professor 
Affiliation  TERNA PHYSIOTHERAPY COLLEGE, NAVI MUMBAI 
Address  Terna Physiotherapy College, Terna Medical College campus, 3rd floor, Near Sarsole Bus Depot, Sector-12, Nerul West-400706 Navi Mumbai, Maharashtra

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone    
Fax    
Email  deepikapuri12@gmail.com  
 
Source of Monetary or Material Support  
Terna Physiotherapy College 
Terna Speciality Hospital and Research Centre 
 
Primary Sponsor  
Name  Deepika Metange 
Address  Terna Physiotherapy College, Terna Medical College Campus, 3rd floor, Near Sarsole Bus Depot, Sector 12, Nerul West- 400706, Navi Mumbai, Maharashtra  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Saraswati Iyer  Physiotherapy School and Centre, Seth G.S. Medical College and KEM Hospital, Parel, Mumbai 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepika Metange  Terna  Terna Physiotherapy College, Terna Medical College Campus 3rd floor, Near Sarsole Bus depot, Sector 12, Nerul West, Navi Mumbai- 400706, Maharashtra
Mumbai (Suburban)
MAHARASHTRA 
9969492915

deepikapuri12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Terna Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Risk of falls in older adults aged 60 years and above 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Older adults aged 60 years or over, of both sexes, who live in the community.
2. Older adults residing for at least six months in the area.
 
 
ExclusionCriteria 
Details  1. Any diagnosed neurological disorders viz. Stroke, Multiple sclerosis, Parkinson’s disease, Alzheimer’s disease.
2. History of orthopaedic disorders (fractures, severe arthritis) which may hinder participation in the tests.
3. Numbness in feet and legs (diabetic neuropathy), Vertigo etc.
4. Problems such as diabetic retinopathy, untreated cataract, glaucoma, macular degeneration, blindness etc.
5. Older adults with inability to communicate e.g., Aphasia, hearing deficits etc.
6. Presence of any known psychiatric conditions (mood disorders, schizophrenia)
7. Diagnosed with any acute medical illness, wheelchair bound or bed ridden.
8. Those residing in old age homes or any such institutions.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Quickscreen Fall Risk assessment Scale
 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. Autonomic nervous system assessment using Compass 31 questionnaire
2. Montreal cognitive assessment (MOCA)
3. Reaction time using DLRT
4. Timed up and Go scale.
5. Balance measures using Four stage balance test and Tinetti (balance and gait subtest).
6. Modified Clinical Test of Sensory Integration for Balance (mCTSIB).
 
1 year 
 
Target Sample Size   Total Sample Size="1250"
Sample Size from India="1250" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1189" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2022 
Date of Study Completion (India) 30/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Falls in older adults are multifactorial in origin with various internal and external factors leading to them. In India, there is no instrument for validated assessment that can assess the risk of falls in the elderly in a simple and fast manner and consequently can be used in primary health care by professionals from different areas.

In India, with increasing urbanization, the urban and rural distinction is widening at a faster pace. The cultural levels, living habits, physical activities, and environments of older adults in urban and rural areas are very different. Hence the study aims to carry out research in two Phases. Phase I we would recruit 1250 subjects. In this we would focus on identifying the prospective fall risk among older adults in urban and rural areas of Maharashtra using clinical evaluative methods and understanding the various risk factors (e.g., age, gender, anthropometric measurements, exercise/ physical activities, co-morbidities, depression, socio-economic status, use of slippers/ walking aids, consumption of tobacco/ alcohol, use of medications, joint pains, ADL scores, joint pains etc.) contributing to the same. The subjects would be then categorized into high risk and low risk of falls based on their scores on Quickscreen Fall Risk Assessment Scale. In phase II of the study, we would follow up 775 subjects from Phase I and aim to establish the diagnostic test properties of the Quickscreen Clinical Fall Risk Assessment Scale in order to establish the best cut-off scores among older adults. We also aim to study the incidence of falls by a 12-month follow-up study in order to see that those at risk of falls actually have a fall or not in a 12-month time span. We would also compare the intrinsic neurological factors (balance, mobility, autonomic dysfunction, reaction time etc.) of falls with older adults at risk and not at risk of falls.

We will estimate the mean and standard deviation (SD), or median and interquartile range (IQR) for continuous variables. We will estimate proportions for categorical variables. The normality of the data will be assessed using the Shapiro-Wilk test. The means will be compared using t-test for two groups or Analysis of Variance (ANOVA) for more than two groups. The distribution for non-parametric data will be compared using the Mann Whitney Wilcoxon test for two groups or the Kruskal Wallis test for more than two groups. The proportions will be compared using the chi square test or Fisher’s exact test for low expected cell counts.

 

For Phase II we will estimate the sensitivity, specificity, positive predictive value, and negative predictive value for prediction of falls in this population. We will also use receiver operating characteristics (ROC) curve for identifying the optimal cut-off. A p value of < 0.05 will be considered statistically significant. Data will be analyzed using Stata Version 17 (© StataCorp, College Station, Texas, USA).

 
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