Amputation
Conditions
Brief summary
About 16% of the world's population suffers from physical disabilities, of which about 65% of the population experience lower limb amputations, and in lower limb about 50% face transtibial amputation and use transtibial prosthesis. The transtibial prosthetic users face many stump-related problems.
Detailed description
As a physical interface, a prosthetic liner is commonly used as a transition material between residual limb and stiff socket to provide optimal comfort, fit, and functionality. By using a prosthetic liner, stump-related issues can be relieved, and long-term use of prosthetic devices achieved by an amputee. Prosthetic liners are so expensive due to being imported that patients can't afford them. My study aims to develop a low-cost prosthetic liner for transtibial amputees to ensure its availability and affordability for patients who need a prosthetic liner, by using material available at a local level like silicon to improve their ability to cushion and protect the residual limb from injuries induced by load-bearing normal and shear stresses. The study includes 1 sample size of 40 years of age males, Participents develop a prosthetic liner and then use it on these samples to determine liner durability and hope the results are in favor.
Interventions
DEVICEUse of Conventional Silicone Prosthetic Liner
At this stage participant who will be fitted with a standard silicone liner typically used for transtibial prosthetics. Over a set duration, we will assess the liner's performance, particularly in terms of durability, comfort, skin health, and fit stability. Acting as the control group, this cohort will provide essential baseline data for comparison with the innovative prosthetic liner.
Sponsors
Superior University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Transtibial amputee with medium stump. * Amputee which has been using the prosthetic leg for 3 years without prosthetic liners. * Amputee with 40 years of age.
Exclusion criteria
* Any other amputees except transtibial. * Amputees without using prosthetic devices. * Amputees above 40 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Socket Comfort Score | 12 Months | The socket comfort score is a numerical rating scale used to assess the comfort of a prosthetic. the score ranges from 0 to 10, with 0 being the least comfortable and 10 being the most comfortable. |
| Timed Up and Go (TUG) | 12 months | This test measures the Time in seconds; lower scores indicate better performance the lower the time is the better the score is. |
| Skin Irritation Scale | 12 months | Skin Irritation Scale deals with the skin irritation (Scores: 0-4, where 0 = no irritation and 4 = severe irritation) |
| 6-Minute Walk Test | 12 months | 6-Minute Walk Test in this test we mesuares the Distance in meters; higher distance indicates better performance |
Countries
Pakistan
Outcome results
None listed