Development And Durability Of Prosthetic Liner For Transtibial Amputee

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Amputation
• Intervention / Treatment: Device: Use of Conventional Silicone Prosthetic Liner

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Peshawar, Khyber Pakhtunkhwa, Pakistan
      • PAK Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Transtibial amputee with medium stump, using the prosthetic leg for 3 years without prosthetic liners. age should be 40 years

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Exp Group

Device: Use 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socket Comfort Score	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.	12 Months
Timed Up and Go (TUG)	This test measures the Time in seconds; lower scores indicate better performance the lower the time is the better the score is.	12 months
Skin Irritation Scale	Skin Irritation Scale deals with the skin irritation (Scores: 0-4, where 0 = no irritation and 4 = severe irritation)	12 months
6-Minute Walk Test	6-Minute Walk Test in this test we mesuares the Distance in meters; higher distance indicates better performance	12 months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MSRSW/Batch-Fall22/757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No