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CTRI Number  CTRI/2025/06/088618 [Registered on: 11/06/2025] Trial Registered Prospectively
Last Modified On: 11/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To see risk factors of falls and participation restriction in fallers and pre-fallers in elderly community individual  
Scientific Title of Study   Investigate the risk factors of falls & participation restriction among community dwelling Frail & Pre-Frail elderly people An Observational Cross-sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratik Rajendra Ingle 
Designation  1st year MPT (Community Physiotherapy) 
Affiliation  Dr. Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar 
Address  Department of Community Physiotherapy Basement Dr Vithalrao Vikhe Patil College of Physiotherapy Vilad Ghat Ahmednagar Ahmadnagar MAHARASHTRA 414111 India Ahmadnagar MAHARASHTRA 414111 India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  9284851315  
Fax    
Email  prateekingle123456@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shyam D Ganvir 
Designation  Principal & Professor Department of Community Physiotherapy 
Affiliation  Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar 
Address  Department of Community Physiotherapy Basement Dr Vithalrao Vikhe Patil College of Physiotherapy Vilad Ghat Ahmednagar Ahmadnagar MAHARASHTRA 414111 India Ahmadnagar MAHARASHTRA 414111 India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  8554990224  
Fax    
Email  shyam.ganvir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shyam D Ganvir 
Designation  Principal & Professor Department of Community Physiotherapy 
Affiliation  Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar 
Address  Department of Community Physiotherapy Basement Dr Vithalrao Vikhe Patil College of Physiotherapy Vilad Ghat Ahmednagar Ahmadnagar MAHARASHTRA 414111 India Ahmadnagar MAHARASHTRA 414111 India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  8554990224  
Fax    
Email  shyam.ganvir@gmail.com  
 
Source of Monetary or Material Support  
DVVPFS College of Physiotherapy opposite government milk dairy MIDC Vilad Ghat Ahmednagar 414111 
 
Primary Sponsor  
Name  Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar 
Address  DVVPFS COLLEGE OF PHYSIOTHERAPY opposite government milk dairy MIDC Vilad Ghat Ahmednagar 414111 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Pratik Rajendra Ingle   DVVPFS College of Physiotherapy vilad ghat Ahmednagar  Department of Community Physiotherapy block one basement Dvvpfs College of Physiotherapy Ahmednagar Ahmadnagar MAHARASHTRA Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 
9284851315

prateekingle123456@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DVVPFS College of Physiotherapy Institutional Ethical CommitteeAhmednagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Community dwelling elderly individual 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Elderly Healthy Population
MMSE
 
 
ExclusionCriteria 
Details  Unwilling to participate
Recent injuries
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
MODIFIED REINTEGRATION TO NORMAL LIVING INDEX  BASELINE 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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)   23/07/2025 
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)   Open to Recruitment 
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  

Falls have multiple causes, including a history of falling, advanced age, limitations in balance and mobility, poor vision, cognitive impairments, illnesses like stroke and Parkinson’s disease, and the use of multiple medications. It is crucial to inquire if all older adults have experienced a fall in the past year. A multifaceted assessment of known risk factors and their management should be implemented to mitigate the risk of falls. Individuals who report a fall should undergo an evaluation of their gait and balance. If instability is detected, a comprehensive fall risk assessment encompassing a detailed fall history, physical examination, functional assessment, and environmental evaluation is recommended. This paper emphasizes the significance of multidimensional fall interventions, particularly targeting modifiable risk factors. Two key elements often included in effective fall prevention strategies are: a) exercises focusing on balance, strength, and gait training, and b) modifications to the home environment. Additionally, reducing or discontinuing psychoactive medications and other medications plays a crucial role in fall prevention. Most frail older adults living in the community after discharge from aged care services are unable to engage in their desired life roles.

The areas most affected by participation restriction were work and community mobility. Participation restriction is associated with factors from other ICF dimensions, including health condition, impairment of body form/function, and activity limitation. Participation is multifactorial in nature. Both grip and quadriceps strength were independently and significantly linked to participation. Balance and mobility, indicated by postural sway, gait speed, use of walking aids, and lower extremity function, also played crucial roles in participation. Participation restriction, considered an aspect of disability by the ICF, was significantly associated with the degree of frailty and the number of concurrent medical conditions. Research by Fried et al. indicated that disability, comorbidity, and frailty are distinct yet overlapping entities in older adults, with disability primarily related to activity limitation and possibly participation restriction. Understanding the extent and nature of participation restriction in frail older adults is crucial in our aging society.

 Understanding the physiological, psychological, and social dimensions of frailty is vital for furthering research in medical gerontology. A clearer concept of frailty can help inform public health policies, enabling better allocation of resources for prevention and care. Defining frailty can improve the clinical management of elderly patients by identifying those at risk and targeting interventions to prevent disability and maintain independence. A robust understanding can guide strategies for primary, secondary, and tertiary prevention, aiming to reduce the burden of diseases associated with aging.

 Frailty is recognized as a critical factor influencing adverse health outcomes, quality of life, healthcare use, and mortality among older adults. It operates independently of other diseases or disabilities. Many existing tools for frailty identification are either too complex for routine use in community or primary care settings or require healthcare professionals for administration. There is a need for a simple, reliable screening method that non-healthcare professionals can use effectively. Frailty is not a fixed state; individuals can transition between robust, pre-frail, and frail conditions over time. Early detection and intervention, particularly in the pre-frail stage, could help slow or reverse the progression to frailty. Previous research has largely focused on psychometric properties and clinical validation of frailty screening tools. However, there has been limited exploration of their applicability in public health or service settings, highlighting a gap in addressing frailty on a broader scale. The FRAIL scale, consisting of five simple items (fatigue, resistance, ambulation, illnesses, and weight loss), is straightforward and does not require professional healthcare administration. Its feasibility in real-world community settings needs further validation to determine its potential for large-scale use.

The use of the mRNL Index as a reliable measure of community reintegration in community-dwelling adults. Assessing reintegration in community-dwelling elderly individuals is crucial, as successful reintegration is associated with improved quality of life and reduced healthcare utilization. The mRNL Index, with its focus on daily functioning and personal integration, offers a comprehensive assessment that can inform targeted interventions to enhance community participation among the elderly.

Despite its potential, there is a need for studies specifically validating the mRNL Index within community-dwelling elderly populations. Such research would confirm its reliability and validity in this demographic, ensuring that the tool accurately reflects the unique challenges and experiences of older adults. Addressing these research gaps, healthcare professionals can better utilize the mRNL Index to assess and promote successful reintegration among community-dwelling elderly individuals, ultimately enhancing their quality of life and community participation.

Therefore, this study is carried out to see the risk factors of falls and participation restriction among elderly community dwellers in Frail and Pre-Frail individual.

 
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