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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Risk of falls in older adults aged 60 years and above |
|
Intervention / Comparator Agent
|
|
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)
|
1 |
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). |