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CTRI Number  CTRI/2022/01/039436 [Registered on: 14/01/2022] Trial Registered Prospectively
Last Modified On: 13/01/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To analyze the relationship between understanding the risk of fall and balance performance of elderly living in the community and comparing it with their quality of life 
Scientific Title of Study   Relationship between perception of fall, balance and quality of life among community-dwelling elderly 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alisha Austin Lobo 
Designation  Lecturer 
Affiliation  Father Muller College of Allied Health Sciences 
Address  Department of Physiotherapy Father Muller College of Allied Health Sciences, Father Muller Road Kankanady Mangaluru

Dakshina Kannada
KARNATAKA
575002
India 
Phone  09663676198  
Fax    
Email  loboalisha90@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sydney Roshan Rebello 
Designation  Professor 
Affiliation  Father Muller College of Allied Health Sciences 
Address  Department of Physiotherapy Father Muller College of Allied Health Sciences, Father Muller Road Kankanady Mangaluru

Dakshina Kannada
KARNATAKA
575002
India 
Phone  09343569219  
Fax    
Email  sydnypt@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Sydney Roshan Rebello 
Designation  Professor 
Affiliation  Father Muller College of Allied Health Sciences 
Address  Department of Physiotherapy Father Muller College of Allied Health Sciences, Father Muller Road Kankanady Mangaluru

Shimoga
KARNATAKA
575002
India 
Phone  09343569219  
Fax    
Email  sydnypt@fathermuller.in  
 
Source of Monetary or Material Support  
Father Muller College of Allied Health Sciences 
 
Primary Sponsor  
Name  Father Muller College of Allied Health Sciences 
Address  Father Muller College of Allied Health Sciences Father Muller Road Kankanady Mangaluru- 575002 
Type of Sponsor  Private medical college 
 
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 
Alisha Austin Lobo  Father Muller Medical College Hospitals  Department of Physiotherapy Father Muller Road Kankanady Mangaluru
Dakshina Kannada
KARNATAKA 		 9663676198

loboalisha90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elderly above 60 years of age 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Community-dwelling elderly 60 years of age and above

2. A score of 25 to 30 on the St. Louis University Mental Status (SLUMS) scale

3. With or without any histories of falls in the past year. A fall was defined as any event in which the individual lost their balance and made contact with the floor (i.e. did not simply fall back into a chair after trying to stand up).

4. Ability to walk with or without assistance for 10 metres. 
 
ExclusionCriteria 
Details  1. Individuals with a history of significant head trauma, neurological disease (e.g Parkinson’s, post-polio syndrome, diabetic neuropathy), visual impairment not correctable with lenses, musculoskeletal impairments (e.g. amputation, joint replacement, joint fusions, joint deformity due to rheumatoid arthritis), or persistent symptoms of vertigo, light-headedness, unsteadiness.

2. History of surgeries in the lower extremities in the last 6 months

3. Elderly i.e. age of 60 years and above who are institutionalized 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Tinette Fall Efficacy Scale- International (FES-I)  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Functional Reach Test (FRT) / Modified Functional Reach Test (mFRT)  At baseline 
Mini Balance Evaluation Systems Test (Mini BESTest)  At baseline 
WHO Quality of Life- BREF (WHOQOL-BERF)  At baseline 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/01/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Falls present a substantial health problem among the elderly. Approximately one-third of older adults fall each year which tends to be fatal. Thirty per cent of people over 65 years and 50% over 80 years old experience at least one fall each year. Evidence shows an estimated 90% of hip fractures result from these falls, leading to limited personal mobility and quality of life. Fear of fall is higher among older adults with the prior occurrence of fall as in “post-fall syndrome”. This could diminish older adults’ confidence in performing activities of daily living, confining them at home leading to social isolation. Cognitively intact as well as impaired older adults share some well-established risk factors for falls, such as fall history, environmental hazards, motor, sensory and visual impairments. Most falls, however, do not result in significant physical injury or death, but the psychological impact of such an event can result in a fear of falling and reluctance to perform activities. Physical, psychological, and functional levels will predicate one’s fear of falling. Postural control is the foundation of our ability to stand and to walk independently for which the brain must rapidly process signals from the visual, vestibular, and somatosensory systems. Deterioration in balance function, whether a natural process related to ageing or as a result of disease, is observed much more often among the elderly than it is within younger individuals. Balance and gait impairments in older people increase the risk of falls which constitute a public health problem associated with high financial costs as well as human suffering. There is a dearth in the literature that correlates the perception of falls and impairment in balance to the quality of life among the community-dwelling elderly population.


AIM: To correlate perception of fall (POF) and balance with the quality of life (QOL) among community-dwelling elderly.

OBJECTIVES:
1. To correlate the perception of fall and balance among community-dwelling elderly
2. To associate perception of fall and balance with the quality of life among community-dwelling elderly.

PROCEDURE:

Community-dwelling elderly 60 years of age and above, with With or without any histories of falls in the past year. A fall was defined as any event in which the individual lost their balance and made contact with the floor (i.e. did not simply fall back into a chair after trying to stand up), with a score of 25 to 30 on St. Louis University Mental Status (SLUMS) scale and ability to walk with or without assistance for 10 metres will be recruited in the study. the purpose of the study will be explained to the eligible participant in their own native language and informed consent will be taken from the willing participant. The demographic data and outcome measures will be then collected.


 
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