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CTRI Number  CTRI/2018/03/012456 [Registered on: 09/03/2018] Trial Registered Prospectively
Last Modified On: 09/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Prosthetics ( External prosthesis for Amputees)]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Walking Analysis of Above Knee Amputees Using Above Knee Prosthesis with Polymeric Polycentric artificial Knee Joint-A Pilot Study 
Scientific Title of Study   Gait Analysis of Above Knee Amputees Using Above Knee Prosthesis with Polymeric Polycentric Prosthetic Knee Joint-A Pilot Study 
Trial Acronym  PPPKJ 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ranjeet Kumar 
Designation  Research Scholar 
Affiliation  Indian Institute of Technology Delhi 
Address  Department of Applied Mechanics Indian Institute of Technology Hauz Khas New Delhi 110016

South
DELHI
110016
India 
Phone  9990138938  
Fax    
Email  ranjisic@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Naresh Bhatnagar 
Designation  Professor 
Affiliation  Indian Institute of Technology Delhi 
Address  Department of Mechanical Engineering Indian Institute of Technology Hauz Khas New Delhi 110016

South
DELHI
110016
India 
Phone  9811326491  
Fax    
Email  narbhat@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Naresh Bhatnagar 
Designation  Professor 
Affiliation  Indian Institute of Technology Delhi 
Address  Department of Mechanical Engineering Indian Institute of Technology Hauz Khas New Delhi 110016

West
DELHI
110016
India 
Phone  9811326491  
Fax    
Email  narbhat@hotmail.com  
 
Source of Monetary or Material Support  
Department of Applied Mechanics Indian Institute of technology Hauz Khas New Delhi 110016 
Department of Physical Medicine and rehabilitation Government Medical College Thiruvananthapuram 695011 
 
Primary Sponsor  
Name  Ranjeet Kumar 
Address  Department of Applied Mechanics Indian Institute of Technology Hauz Khas New Delhi 110016 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Abdul Gafoor S  Department of Physical Medicine and Rehabilitation Government Medical College Thiruvananthapuram 695011 
Dr George Zachariah  Department of Physical Medicine and Rehabilitation Government Medical College Thiruvananthapuram 695011 
Dr Jijo Varghese  Department of Physical Medicine and Rehabilitation Government Medical College Thiruvananthapuram 695011 
Prof Naresh Bhatnagar  Department of Mechanical Engineering Indian Institute of Technology Hauz Khas New Delhi 110016 
Prof Puneet Mahajan  Department of Applied Mechanics Indian Institute of Technology Hauz Khas New Delhi 110016 
Shaju V Cherian   Department of Physical Medicine and Rehabilitation Government Medical College Thiruvananthapuram 695011 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr George Zachariah  Gait Analysis lab Department of Physical Medicine and Rehabilitation  Government Medical College Thiruvananthapuram
Thiruvananthapuram
KERALA 		 9447603090

zackisgeorge@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee Government Medical College Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Above Knee Amputees,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Above Knee Prosthesis with Polymeric Polycentric Prosthetic Knee Joint  Walking Training of above knee amputees using Above Knee Prosthesis with Polymeric Polycentric Prosthetic Knee joint for 1 week 
Comparator Agent  Conventional Above Knee Prosthesis   Walking of Above Knee Amputees using conventional Above Knee Prosthesis that the person is already using  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Unilateral transfemoral amputation with at least 15 years of age
2. Medicare Functional Classification Level 2 or 3
3. willing to accept the developed prosthesis
4. Able to walk a distance of minimum 4 meters
5. willing to attend hospital based rehabilitation program 
 
ExclusionCriteria 
Details  1. Significant fluctuation in stump volume within the last 6 months
2.Other neuromuscular problems or a partial amputation of the contralateral limb
3.Physical signs of musculoskeletal abnormalities, other medically unstable conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the gait parameters of a person with transfemoral amputee using an Above Knee Prosthesis with Polymeric Prosthetic Polycentric Knee Joint  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
To study the Energy expenditure by measuring Physiological Cost Index   1 Week 
To study user satisfaction aspects of gait of above knee amputees with above knee prosthesis using revised Patient Evaluation Questionaire  1 week 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/03/2018 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
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 active control single centre study. To primarily analyze the gait parameters  using 3D Gait Analyzer (like Cadence,step length etc) of clinically stable above knee amputees using above knee prosthesis with polymeric polycentric prosthetic knee joint after one week of walking training( polycentric knee joints are commonly used knee joints in above knee prosthesis for above knee amputees) and secondarily to measure energy expenditure using physiological cost index( heart rate/ pulse rate measured using pulse oxymeter) and user satisfaction using revised patient evaluation questionairre.  To compare the above parameters in above knee amputees using conventional above knee prosthesis for 20 patients with above knee amputations attending Department of Physical Medicine and Rehabilitation, Government Medical College, Thiruvananthapuram after getting informed consent. 
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