Health Condition 1: S581- Traumatic amputation at level between elbow and wrist
Conditions
Interventions
Intervention1: Grippy® Advanced - Upper Limb Prosthetic Arm: Battery Powered 3D Printed Artificial hand for 5 Session of evaluation
Control Intervention1: Not Aplicable: Not Aplicable
Sponsors
Bionic Hope Private Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| 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.Timepoint: recorded at fitment, 1,2, 3, 6 and 12 weeks after fabrication of the 3D Printing based prosthesis. | — |
Countries
India
Contacts
Public ContactMr Salil Jain
Sancheti Institute for Orthopaedics and Rehabilitation
Outcome results
None listed