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CTRI Number  CTRI/2022/09/045300 [Registered on: 07/09/2022] Trial Registered Prospectively
Last Modified On: 06/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Non target and target oriented functional reach in elderly persons 
Scientific Title of Study   To Analyse difference between Non target and Target oriented functional reach among elderly population 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeetha B 
Designation  Student 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  No 6 VOC Nagar Extension, Peethambaram Complex Phase-II, Sathuvachari, Vellore.
Faculty Of Physiotherapy Sri Ramachandra Institute Of Higher Education And Research Porur CHENNAI-600116.
Chennai
TAMIL NADU
632009
India 
Phone  9894480896  
Fax    
Email  t0320003@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Radhika CM 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Faculty Of Physiotherapy, Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai.

Chennai
TAMIL NADU
600116
India 
Phone  9841376961  
Fax    
Email  radhikacm@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Radhika CM 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Faculty Of Physiotherapy, Sri Ramachandra Institute Of Higher Education And Research, PORUR, CHENNAI.

Chennai
TAMIL NADU
600116
India 
Phone  9841376961  
Fax    
Email  radhikacm@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
faculty of physiotherapy sri ramachandra institute of higher education and research 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [nil] 
 
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 
SANGEETHA B  Faculty Of Physiotherapy  Faculty Of Physiotherapy (Outpatient department), Sri Ramachandra Institute Of Higher Education And Research, PORUR, CHENNAI -600116
Chennai
TAMIL NADU 
9894480896

t0320003@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ELDERLY POPULATION 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NL 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Both male and female 65 years and above
Asymptomatic individuals
Subject lining in community who can ambulate with or without walking aids
Shoulder flexion and abduction within the range and ankle dorsiflexion range present which doesn’t affect the test.
Subject should stand independently for atleast 30 seconds
 
 
ExclusionCriteria 
Details  Subject with severe musculoskeletal conditions requiring active management
Neurological disorders such as stroke, brain injury, multiple sclerosis, peripheral neuropathy, vertigo and whiplash injury.
Blindness and deafness
Cardio-respiratory disorder
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fall efficacy scale
Forward reach test
Target-oriented forward reach
Lateral reach test
Target-oriented lateral reach 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   NIL 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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)   12/09/2022 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary     Aging is often accompanied by decreased muscle strength, aerobic capacity, balance and gait which can lead to impaired physical performance and experience difficulty in the activities of daily living (ADL). Balance is maintained by interaction between Visual, vestibular and proprioceptive, thus involvement of any one of these systems can cause balance impairment. If balance is affected then it will also affect the flexibility. Measurement of balance is an important component of balance rehabilitation, both static and dynamic balance abilities are considered integral parts of flexibility skills. The Functional Reach Test (FRT) and Lateral Reach Test (LRT) are two commonly used tools that measure dynamic balance.

             The Functional Reach Test evaluates the forward stability of a standing subject who voluntarily extends one arm as far forward as possible in the horizontal plane, while keeping both heels    in contact with the ground. The score is obtained by measuring the distance between fingertips’s starting and end position. The FRT score correlates with the anteroposterior excursion of the    centre of pressure (CoP). The FRT has demonstrated good test-retest and inter rater reliability, and it can predict community-dwelling older adults who are at a high risk for falling, which is    a marker of frailty and functional dependency.

         The lateral reach test measures lateral postural stability by assessing the maximum distance an individual can reach laterally while standing in a fixed position. The test is correlated with     center of pressure excursion and has high test-retest reliability, thereby supporting its use as a clinical indicator of medial-lateral postural stability and its use as an indicator of risk of falling.

          A task similar to functional reach and lateral reach is incorporated that is to reach a target among the elderly subjects in order to find the difference. A major difference compared to reaching   task is to reach for a target object. The test was considered successfully completed when the subject grasped the circumference of the object and reached the target of the object returned to     an upright standing position. The maximum distance achieved by the subject beyond his/her FR score was recorded as the target-oriented functional reach score.

            It would seem that the task of Functional Reach, lateral reach and the task of reaching on targeted object would likely produce different quantitative results since they are not identical tasks.

           This study is done to analyse difference between non target and target oriented functional reach among elderly population with and without fear of fall.

Ag

 
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