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CTRI Number  CTRI/2021/02/031405 [Registered on: 18/02/2021] Trial Registered Prospectively
Last Modified On: 22/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Battery Powered 3D Printed Artificial hand made for use in persons with limb loss below the level of the elbow Study 
Scientific Title of Study   Clinical Evaluation of Quality of Life and Effectiveness parameters with 3D Printed Mechano Myogram (MMG)based prosthesis with VibroTactile Feedback: A pilot study of Grippy® Advanced 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Salil Jain 
Designation  Prosthesis & Orthesis Consultant 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation 
Address  Orthotic Prosthetic Department, Basement, Atlantis, 11/12 Thube Park 16, Shivajinagar

Pune
MAHARASHTRA
411005
India 
Phone  9371010925  
Fax    
Email  mahavir_ent@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Mr Salil Jain 
Designation  Prosthesis & Orthesis Consultant 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation 
Address  Orthotic Prosthetic Department, Basement, Atlantis, 11/12 Thube Park 16, Shivajinagar

Pune
MAHARASHTRA
411005
India 
Phone  9371010925  
Fax    
Email  mahavir_ent@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Mr Salil Jain 
Designation  Prosthesis & Orthesis Consultant 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation 
Address  Orthotic Prosthetic Department, Basement, Atlantis, 11/12 Thube Park 16, Shivajinagar

Pune
MAHARASHTRA
411005
India 
Phone  9371010925  
Fax    
Email  mahavir_ent@yahoo.com  
 
Source of Monetary or Material Support  
Bionic Hope Private Limited 
BIRAC SBIRI GRANT 
Sancheti Hospital 
 
Primary Sponsor  
Name  Bionic Hope Private Limited 
Address  Robo Bionics, 1st Floor, Pearl Haven, Kumbharwada, Manickpur, Vasai, Maharashtra 401202 
Type of Sponsor  Other [Medical Device Manufacturing Company Indian] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uttara Deshmukh  MGM Institute of Health Sciences  MGM Institute’s University Department of Prosthetics & Orthotics, Sector-1, Kamothe, Navi Mumbai 410209
Raigarh
MAHARASHTRA 
8888863363

mgmudpo@mgmuhs.com 
Mr Salil Jain  Sancheti Institute for Orthopaedics and Rehabilitation  Orthotic Prosthetic Department, Basement, Atlantis, 11/12 Thube Park 16, Shivajinagar
Pune
MAHARASHTRA 
9371010925

mahavir_ent@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee for Research on Human Subjects, MGM Institute of Health Sciences  Approved 
Institutional Ethics Committee, Sancheti Institute for Orthopaedics and Rehabilitation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S581||Traumatic amputation at level between elbow and wrist,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Grippy® Advanced - Upper Limb Prosthetic Arm  Battery Powered 3D Printed Artificial hand for 5 Session of evaluation 
Comparator Agent  Not Aplicable  Not Aplicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients with unilateral or bilateral below elbow amputation
2. Amputation due to vascular, traumatic, diabetes or other causes
3. Using or have used Body Powered or Battery Powered Prosthesis
4. Amputees who are willing to attend 4 to 5 number of follow up visits at
Sancheti Hospital
5. Stump Length Below Elbow of atleast 5 inches and Stump age of atleast 3 Months 
 
ExclusionCriteria 
Details  1 Age is less than 18 years or more than 75 years
2 Functional impairments in the sound limb
3 Presence of ulcer or open wound over the distal end of the residual limb
4 Mental or cognitive disorder interfering with dexterity or cooperation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Nature of Object identification test to measure the accuracy of the user to detect a list of 5 objects and to correctly identify the nature, soft or hard of objects

2 Ten Object Handling test. To record time taken to move 10 objects from Point A to B to assess the duration required to learn to operate the device

3 Two minute weight pick test:
i In a hook grip
ii In Palmer grip
to assess the comfort of a person when handling weight and evaluates the effectiveness of the Device 
The measurements would be done consequently after fitment, after 1,2, 3, 6 and 12 weeks of fabrication and fitment of the 3D Printing based prosthesis. 
 
Secondary Outcome  
Outcome  TimePoints 
1 Comparison Index to evaluate a device Comparison index of the conventional prosthesis with the 3D printed prosthesis If the prior Body powered or battery-powered active prosthesis of the user is available

2 Customization index to estimate the time needed by the Technician who is fitting the prosthesis to carry out any customization or modifications in the software of the
device.

3 Patient satisfaction assessed by Prosthesis Evaluation Questionnaire and Quality of Life Questionnaire. 
recorded at fitment, 1,2, 3, 6 and 12 weeks after fabrication of the 3D Printing based prosthesis.

 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   22/02/2021 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The below-elbow artificial limb (prosthesis) consists of a Socket and a Gripper. The socket is the part which is in direct contact with the residual limb and serves as an interface between the stump and the artificial limb (prosthesis). Upper extremity artificial limb (prosthesis) components are made using a wide variety of materials such as Wood, Plastic, Metal and Carbon fibre.

This study aims to assess the efficacy of incorporating a cost-effective material like Polycarbonate, Acrylonitrile styrene acrylate or Polyurethane, while using a cost-effective additive Manufacturing process known as 3D Printing, as a component in the below-elbow artificial limb, while following fabrication of the prosthetic socket as per current good clinical practices. This may make the prosthesis cheaper, lighter and easy to maintain in the community. In addition, the amputee’s may be able to handle a variety of objects without relying too much on visual feedback and without the assistance of any other person. The ability to handle day to day objects independently is important with reference to social and cultural practices in India. In the event of a natural disaster, fabrication of a 3D Printed prosthesis may be easier as compared to the conventional prosthesis. 

Patients with below elbow amputation would be screened in the Department of Prostheses and Orthoses for fulfilling the eligibility criteria. Participants must have been using body-powered or battery-powered hand prosthesis for at least six months. For those who consent to participate in the study, a 3D Printed below elbow artificial limb (transradial prosthesis) would be fabricated. The primary outcome measures which would be used in the study (10 object handling test, 2 minute Weight Pick test, Nature of Object Identification test have been validated. Quality of life analysis would be done in the lab of Department of Prostheses and Ortheses - initially at the first visit with a conventional below elbow artificial limb (transradial prosthesis) if available and then after 1, 3, 6 and 12 weeks of fabrication and fitment of the 3D Printed below elbow artificial limb (transradial prosthesis). Prosthesis Evaluation Questionnaire would be filled at the initial visit and after 3 weeks of fabricating 3D Printed artificial limb (prosthesis) to assess the learning time of the 3D Printed Prosthesis, Object Handling, Nature of Object Identification and patient satisfaction. Data would then be compared and reported. During the Trial, the patient will not be permitted to take the device home.

 
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