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CTRI Number  CTRI/2017/08/009464 [Registered on: 23/08/2017] Trial Registered Retrospectively
Last Modified On: 22/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To Find the association of limb movements with risk of falling in community dwelling older adults.  
Scientific Title of Study   To study the association of interlimb coordination with fall risk in community dwelling older adults. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sibadiuty Mohapatra 
Designation  Postgraduate student 
Affiliation  School of Allied Health Sciences, Manipal University 
Address  Department of Occupational Therapy. School of Allied Health Science Manipal University,Udupi

Udupi
KARNATAKA
576104
India 
Phone  9448758279  
Fax    
Email  sibadiuty.motneuro@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sebestina Anita Dsouza 
Designation  Professor and Head 
Affiliation  Manipal University 
Address  Department of Occupational Therapy. School of Allied Health Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448152143  
Fax    
Email  sebestina.dsouza@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sebestina Anita Dsouza 
Designation  Professor and Head 
Affiliation  Manipal University 
Address  Department of Occupational Therapy. School of Allied Health Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448152143  
Fax    
Email  sebestina.dsouza@manipal.edu  
 
Source of Monetary or Material Support  
Department of Occupational Therapy. School Of Allied health Science, Manipal university,manipal.karnataka 
 
Primary Sponsor  
Name  not applicable 
Address  not applicable 
Type of Sponsor  Other [not applicable] 
 
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 
Dr Sibadiuty Mohapatra  Kasturba Hospital  Community Health Care Centers,Temples,Community Parks manipal udupi
Udupi
KARNATAKA 		 9448758279

sibadiuty.motneuro@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal elderly people who are aged over 65 years of age.  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.participants should be able to comprehend the test procedures.

2.participants should be able to ambulate by self.

3.Person using any canes or crutches for ambulation will be included in the study. 
 
ExclusionCriteria 
Details  Older adults who have acute or definitive diagnosis of any neurological and psychiatric illness will be excluded from the study. Participants who currently have an upper extremity fracture or dislocation will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
significance of association of interlimb coordination with risk of fall in community dwelling older adults.  2 months after the completion of data collection 
 
Secondary Outcome  
Outcome  TimePoints 
if the test results are significant the "Marching-in-place" can be used as a screening tool to assess fall risk in community dwelling older adults.  test is for 30 seconds, if the person having good interlimb coordination then he does nit the risk of fall. 
 
Target Sample Size   Total Sample Size="285"
Sample Size from India="285" 
Final Enrollment numbers achieved (Total)= "236"
Final Enrollment numbers achieved (India)="236" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2016 
Date of Study Completion (India) 28/07/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Older adults are more prone to falls. previous study reports that interlimb coordination may be a factor to risk of fall in older adults.
So this study aimed to examine the association of interlimb coordination with risk of fall in communty dwelling older adults.
Null hypothesis: there is no association between the interlimb coordination and risk of fall in community dwelling older adults.
Alternate hypothesis; there is an association of interlimb coordination with fall risk in community dwelling older adults.
older adults aged 65 to 80 years were selected for the study. fall risk assessment screening was done using "timed up and go test" and " four square step test". following that, test of "Marching-in-place" was done to assess the quality of interlimb coordination.
the data will be analysed using the chi-square test to determine the association of interlimb coordination and risk of fall in community dwelling older adults. and the psychometric properties will be determined. 
if the test result proves the alternate hypothesis correct, then the "marching-in-place " test can be used as a screening tool to assess the risk of fall in community dwelling older adults. 

 
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