Development And Durability Of Prosthetic Liner For Transtibial Amputee

NCT06762847 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/757
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Exp Group

Device: Use of Conventional Silicone Prosthetic Liner

Interventions

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.

Exp Group

Eligibility Criteria

• Age: 40 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Any other amputees except transtibial.
• Amputees without using prosthetic devices.
• Amputees above 40 years of age.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

PAK Rehabilitation Centre

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 8, 2025
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)