Battery Powered 3D Printed Artificial hand made for use in persons with limb loss below the level of the elbow Study

Recruiting

Conditions: Traumatic amputation at level between elbow and wrist,

Registration Number: CTRI/2021/02/031405

Lead Sponsor: Bionic Hope Private Limited

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 amputeeâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 15

Inclusion Criteria

Patients with unilateral or bilateral below elbow amputation 2.
Amputation due to vascular, traumatic, diabetes or other causes 3.
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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3 Two minute weight pick test:	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.
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	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.
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	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.
ii In Palmer grip	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.
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.
i In a hook grip	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 Measures

Name	Time	Method
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

Trial Locations

Locations (2): MGM Institute of Health Sciences
🇮🇳
Raigarh, MAHARASHTRA, India
Sancheti Institute for Orthopaedics and Rehabilitation
🇮🇳
Pune, MAHARASHTRA, India
MGM Institute of Health Sciences
🇮🇳Raigarh, MAHARASHTRA, India
Dr Uttara Deshmukh
Principal investigator
8888863363
mgmudpo@mgmuhs.com