Development And Durability Of Prosthetic Liner For Transtibial Amputee

Active, not recruiting

• Conditions: Amputation

• Registration Number: NCT06762847
• Lead Sponsor: Superior University

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.

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-08-01
• Study First Submitted: 2024-12-13
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

PAK Rehabilitation Centre; 🇵🇰 Peshawar, Khyber Pakhtunkhwa, Pakistan