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CTRI Number  CTRI/2019/07/020059 [Registered on: 05/07/2019] Trial Registered Prospectively
Last Modified On: 12/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of effectiveness of IndoKnee during knee flexion and extension 
Scientific Title of Study   A non-randomized single arm trial to evaluate the effectiveness of IndoKnee during Knee flexion and extension. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil Kumar Jain 
Designation  Honorary Consultant and Head of Department Dr. P.K. Sethi Department of Physical Medicine and Rehab 
Affiliation  Santokba Durlabhji Memorial Hospital cum Medical Research Institute 
Address  Dr. P.K. Sethi Department of Physical Medicine and Rehab, Santokba Durlabhji Memorial Hospital cum Medical Research Institute Bhawani Singh Marg, Near Rambagh circle, Jaipur- (Rajasthan), INDIA

Jaipur
RAJASTHAN
302015
India 
Phone  9829061496  
Fax    
Email  pksrc@sdmh.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Kumar Jain 
Designation  Honorary Consultant and Head of Department Dr. P.K. Sethi Department of Physical Medicine and Rehab 
Affiliation  Santokba Durlabhji Memorial Hospital cum Medical Research Institute 
Address  Dr. P.K. Sethi Department of Physical Medicine and Rehab, Santokba Durlabhji Memorial Hospital cum Medical Research Institute Bhawani Singh Marg, Near Rambagh circle, Jaipur- (Rajasthan), INDIA

Jaipur
RAJASTHAN
302015
India 
Phone  9829061496  
Fax    
Email  pksrc@sdmh.in  
 
Details of Contact Person
Public Query  
Name  Dr Anil Kumar Jain 
Designation  Honorary Consultant and Head of Department Dr. P.K. Sethi Department of Physical Medicine and Rehab 
Affiliation  Santokba Durlabhji Memorial Hospital cum Medical Research Institute 
Address  Dr. P.K. Sethi Department of Physical Medicine and Rehab, Santokba Durlabhji Memorial Hospital cum Medical Research Institute Bhawani Singh Marg, Near Rambagh circle, Jaipur- (Rajasthan), INDIA

Jaipur
RAJASTHAN
302015
India 
Phone  9829061496  
Fax    
Email  pksrc@sdmh.in  
 
Source of Monetary or Material Support  
Newndra Innovations Private Limited Regd Address: 133B, Dronpuri, Opposite Chitrakoot 200ft Bypass Vaishali Nagar Jaipur 302021 India Corporate Office: KTR-8, Rohit Hospital Lane, DCM, Ajmer Road, Jaipur 302021 India Newndra Innovations is supported by BIRAC, Govt of India. 
 
Primary Sponsor  
Name  Newndra Innovations Pvt Ltd 
Address  1st Floor,KTR8, Rohit Hospital Lane, Near Element Mall, DCM, Ajmer Road, Jaipur 302021, India 
Type of Sponsor  Other [Private Limited Company ] 
 
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 Anil Kumar Jain  Dr. P.K. Sethi Department of Physical Medicine and Rehab  Dr. P.K. Sethi Department of Physical Medicine and Rehab, Santokba Durlabhji Memorial Hospital cum Medical Research Institute Bhawani Singh Marg, Near Rambagh circle, Jaipur-302015 (Rajasthan), INDIA
Jaipur
RAJASTHAN 		 9829061496

pksrc@sdmh.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Santokba Durlabhji Memorial Hospital cum Medical Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal Healthy Person with BMI between 18 to 30, and age between 18 to 70 years with height between 145 to 180 cm who can frequently perform knee flexion and extension tasks. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IndoKnee (A device for knee support)  Use IndoKnee (A device for knee support) for 2-4 weeks, perform tasks involving knee flexion and extension. 
Comparator Agent  Without IndoKnee (A device for knee support)  Without using IndoKnee (A device for knee support) for 2-4 weeks, perform tasks involving knee flexion and extension. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Healthy Male and Female subjects.
Age should be between 18 years to 70 years
Height should be between 145cm to 180cm
Normal Healthy Person (BMI should be between18 to 30).
 
 
ExclusionCriteria 
Details  Cases of known or suspected knee injury, Knee replacement, Knee surgery
Subjects underwent surgery or advised not to squat
Pregnant women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate the effectiveness of using IndoKnee during knee flexion and extension by assessing the EMG data

Analysis of EMG data shows the effectiveness or non-effectiveness of using IndoKnee
 		 1 Year
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the ease of use, risks and adverse effects and get feedback for the device, understand the gap between device and user requirements.  1 Year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   09/07/2019 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 First round of trails on 30 subjects completed. Publication would be planned with recruitment. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study is a non-randomized, single arm, single center trials on 30 subjects in India during knee flexion and extension tasks like sitting down from standing position and standing up from seated position without using the IndoKnee and with using the IndoKnee.

 The primary objective of trial is to evaluate the effectiveness of IndoKnee during knee flexion and extension tasks by assessing the EMG data. The secondary objective of trails is to assess the ease of use, risks & adverse effect and get feedback of the device. Other objective is to understand the gap between device and requirements.

 
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