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CTRI Number  CTRI/2022/12/048184 [Registered on: 16/12/2022] Trial Registered Prospectively
Last Modified On: 19/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Awareness about the risk of falls in older people. 
Scientific Title of Study   Public Awareness of Fall Risk in Elderly 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prince Rohilla 
Designation  Post Graduate Student  
Affiliation  Amar Jyoti Institue of Physiotherapy 
Address  Amar Jyoti Institute of Physiotherapy, Neurology Lab, Third Floor, Vikas Marg, Karkardooma, East Delhi, New Delhi.

East
DELHI
110092
India 
Phone  9953872140  
Fax    
Email  princephysio98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sampada Jahagirdar 
Designation  Assistant Professor 
Affiliation  Amar Jyoti Institute of Physiotherapy 
Address  Amar Jyoti Institute of Physiotherapy, Neurology Lab, Third Floor, Vikas Marg, Karkardooma, East Delhi, New Delhi.

East
DELHI
110092
India 
Phone  9810991128  
Fax    
Email  s.jahagirdar@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sampada Jahagirdar 
Designation  Assistant Professor 
Affiliation  Amar Jyoti Institute of Physiotherapy 
Address  Amar Jyoti Institute of Physiotherapy, Neurology Lab, Third Floor, Vikas Marg, Karkardooma, East Delhi, New Delhi.

East
DELHI
110092
India 
Phone  9810991128  
Fax    
Email  s.jahagirdar@yahoo.co.in  
 
Source of Monetary or Material Support  
Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, East Delhi, New Delhi-92 
 
Primary Sponsor  
Name  Prince Rohilla 
Address  B 26, Saraswati Kunj, Najafgarh, South West, New Delhi-110072 
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 
Prince Rohilla  Amar Jyoti Institute of Physiotherapy  Neurology Lab, Third Floor, Vikas Marg, Karkardooma, East Delhi, New Delhi.
East
DELHI 
9953872140

princephysio98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amar Jyoti Institutional Review Board- Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Individuals are participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  PHASE 1: Development of Questionnaire

1 (a) For Questionnaire Validation:
The professionals from the field of geriatric rehabilitation working closely with older adults for a minimum of 5 years which includes Doctors (experienced in Geriatric Medicine), Physiotherapists working in academic and clinical institutions, Sociologist, and Psychologist.

1 (b) For Internal consistency:
Adults aged 18 years and above
Able to understand Hindi or English.

PHASE 2: Evaluation of Public Awareness Regarding Risk Factors of Fall in Elderly

Community living adults aged 18 years and above.
Ability to understand Hindi or English 
 
ExclusionCriteria 
Details  PHASE 1: Development of Questionnaire

1 (a). All excluded except inclusion criterion
1 (b). The professionals from the field of geriatric rehabilitation working closely with older adults.


PHASE 2: Evaluation of Public Awareness Regarding Risk Factors of Fall in Elderly

The professionals from the field of geriatric rehabilitation working closely with older adults.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Responses to Questionnaire
 
One Time  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="384"
Sample Size from India="384" 
Final Enrollment numbers achieved (Total)= "394"
Final Enrollment numbers achieved (India)="394" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/12/2022 
Date of Study Completion (India) 30/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/09/2023 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Other (Terminated) 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Brief Introduction

According to WHO, there are several risk factors listed due to which the majority of falls occur. These risk factors can be classified into Intrinsic and extrinsic factors. Intrinsic risk factors include age, gender, ethnicity, living alone, medicines, medical condition, impaired mobility, sedentary lifestyle, psychological status, nutritional deficiencies, impaired cognition, visual impairments, foot problems etc. Extrinsic include environmental hazards (poor lighting, slippery floors, uneven surfaces, etc.), footwear and clothing, inappropriate walking aids or assistive devices. (Todd & Skelton 2004)

As prevention is better than cure, falls can be prevented by strategies aiming to modify these risk factors. Some risk factors are modifiable, especially extrinsic. We can modify them only when we know about them. It is our responsibility as a society to make our environment conducive to people of all ages. Thus, it is important that not only the old but even young people should know about the risk factors of falls that can be managed.

Purpose of the Study

Till date, there is no study that gives information on the knowledge of the general population regarding the risk factors of falls among the elderly. This study is needed to assess and analyze the awareness of the general population on the topic. The knowledge gained from this study will enable us to direct appropriate actions and interventions as needed for the pursuit of creating a safe and secure environment for our older generation.

Research Question (As Hypothesis is not applicable)

What is the level of awareness of fall risks of the Indian elderly among the general population?

 
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