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CTRI Number  CTRI/2023/03/050682 [Registered on: 14/03/2023] Trial Registered Prospectively
Last Modified On: 13/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To test the consistency, accuracy and sensibility of Pedalo® -Sensamove-Balance Device in older adults. 
Scientific Title of Study   Establishing the reliability, validity and responsiveness of Pedalo® -Sensamove-Balance Device for assessing balance in 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 Zubia Veqar 
Designation  Associate Professor 
Affiliation  Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  veqar.zubia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Zubia Veqar 
Designation  Associate Professor 
Affiliation  Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  veqar.zubia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Khushboo Tyagi 
Designation  Post Graduate Student 
Affiliation  Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia

South
DELHI
110025
India 
Phone  9958084508  
Fax    
Email  khushbootyagi.97@gmail.com  
 
Source of Monetary or Material Support  
Jamia Millia Islamia 
 
Primary Sponsor  
Name  Jamia Millia Islamia  
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, DELHI-110025, India 
Type of Sponsor  Government funding agency 
 
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 Zubia Veqar  Jamia Millia Islamia  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, Delhi- 110025
South
DELHI 		 9958993486

veqar.zubia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, JAMIA MILLIA ISLAMIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Older Adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age above 60 years
MMSE score equal to or more than 25
Walk independently
 
 
ExclusionCriteria 
Details  Any orthopedic surgery of the lower limb, spine and pelvis within 6 months.
Any implants in the axial skeleton lower limb
Any visual or auditory impairment without correction
Unstable acute or chronic medical condition (severe hypertension, uncontrolled diabetes,
vertebrobasilar insufficiency)
Acute illness within the past 3 weeks ( MI, stroke,)
History of or symptoms of any neurological or vestibular disorder
Any medication that affects the balance mechanism
Criteria for frailty based on grip strength, gender and body mass index (BMI)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Centre of pressure (COP) Range,
2) Centre of pressure (COP) Sway 		 for test-retest reliability at day 1 and after 3 days
for responsiveness- after 4 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Functional Reach Test (FRT)
One leg standing (OLS)
Timed up and go test (TUG) 		 ON DAY 1 for validity 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   18/03/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Alternate hypothesis of the study - Pedalo® Sensamove Balance Device will be a reliable, valid and responsive device to measure balance outcomes in community dwelling older adults.
Before the initiation of the study, approval taken from the institutional ethical committee, Jamia Millia Islamia, New Delhi. Participants will be informed that participating in this study is voluntarily and that they will be free to leave the study at any time. Posters inviting for voluntary participation of older adults will be distributed at recreational centers, senior residences, parks from nearby communities and Jamia Millia Islamia. 
Participants will be recruited from Jamia Millia Islamia and community and informed consent would be signed. All identifying information and demographic data will be kept confidential. Following familiarization, first data will be collected for the  Pedalo® Sensamove Balance Device to measure COP range in all the four directions (front, back, left and right) and COP sway (Antero-posterior, medio-lateral). After that three clinical tests OLS, FRT and TUG will be performed for the Validity. Second readings for balance measures COP range and COP sway will be collected using  Pedalo® Sensamove Balance Device after a gap of 3 days to check the Test-Retest Reliability. Participants will perform 4- weeks of balance exercises at home and after completion of exercises, the final readings for COP range and COP sway will be collected using  Pedalo® Sensamove Balance Device to find the responsiveness of the same balance device.

 
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