Battery Powered 3D Printed Artificial hand made for use in persons with limb loss below the level of the elbow Study
Not Applicable
- Conditions
- Health Condition 1: S581- Traumatic amputation at level between elbow and wrist
- Registration Number
- CTRI/2021/02/031405
- Lead Sponsor
- Bionic Hope Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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
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 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 <br/ ><br> <br/ ><br>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 <br/ ><br> <br/ ><br>3 Two minute weight pick test: <br/ ><br>i In a hook grip <br/ ><br>ii In Palmer grip <br/ ><br>to assess the comfort of a person when handling weight and evaluates the effectiveness of the DeviceTimepoint: 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 <br/ ><br> <br/ ><br>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 <br/ ><br>device. <br/ ><br> <br/ ><br>3 Patient satisfaction assessed by Prosthesis Evaluation Questionnaire and Quality of Life Questionnaire.Timepoint: recorded at fitment, 1,2, 3, 6 and 12 weeks after fabrication of the 3D Printing based prosthesis. <br/ ><br> <br/ ><br>