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
|
|
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
|
|
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. |