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NCT Number: NCT06762847

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Amputation

Age range

40 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PAK Rehabilitation Centre

Peshawar, Khyber Pakhtunkhwa, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Use of Conventional Silicone Prosthetic Liner

Device

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.

Primary outcomes

  1. Socket Comfort Score

    Time frame: 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.

  2. Timed Up and Go (TUG)

    Time frame: 12 months

    This test measures the Time in seconds; lower scores indicate better performance the lower the time is the better the score is.

  3. Skin Irritation Scale

    Time frame: 12 months

    Skin Irritation Scale deals with the skin irritation (Scores: 0-4, where 0 = no irritation and 4 = severe irritation)

  4. 6-Minute Walk Test

    Time frame: 12 months

    6-Minute Walk Test in this test we mesuares the Distance in meters; higher distance indicates better performance

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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