Effects of Pin and Vacuum Assisted Suspension Systems

Prosthesis User Clinical Trial

Official title:

A Comparison of the Effects of Pin and Vacuum Assisted Suspension Systems in Transtibial Amputees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155762
• Other study ID #: GO 15/123
• Status: Completed
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: February 1, 2019

Study information

• Verified date: November 2019
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was performed to determine the presence of any difference between Pin Suspension (PS) and Active Vacuum Suspension (AVS) on walking capacity, functional mobility, weight bearing in the prosthetic side, prosthetic satisfaction and body image were evaluated. Nine patients who don't have an obstacle to both socket applications in terms of stump height, type and edema were evaluated in this study. Both suspension systems were administered to the patients included in the study. First, amputees have used PS for 3 months following alignment of the prosthesis and training period. Then again they used AVS for 3 months following alignment of the prosthesis and training period. For each system, after adapting prosthesis 'LASAR posture' was used to evaluate weight bearing on the prosthetic side, '6 Minute Walk Test' for walking capacity, 'Time Up and Go' test for functional mobility, 'Prosthetic Satisfaction Index' for prosthetic satisfaction and 'Amputee Body Image Scale' for body. There were statistically significant difference between PS and AVS in terms of prosthetic side weight bearing percentage, walking capacity, functional mobility and prosthetic satisfaction (p<0.05), in favor of AVS. There were not statistically significant difference between the body image scores (p>0.05). From the view of function and prosthetic satisfaction, AVS was found to be more effective in transtibial amputees. It is believed that our study will be a guide to the future studies including higher number of amputees, different amputation levels and different suspension systems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being able to walk without the use of any assistive device,

• Having normal range of motion in the hip and knee at the amputated side.

Exclusion Criteria:

• Having any disadvantage about prosthetic device usage in terms of stump length, shape and edema,

• Having movement limitation,

• Having any discomfort or health problem (cardiopulmonary, neurological or orthopedic problems) that may affect gait other than amputation,

• Having multiple extremity loss.

Related Conditions & MeSH terms

• Amputees
• Artificial Limbs
• Prosthesis User

Intervention

Other:
• Pin Suspension System (a prosthetic suspension system)
Participants used the PSS for three months following fabrication and adjustment of the prosthesis, and a prosthetic training period.
• Vacuum-Assisted Suspension System (a prosthetic suspension system)
After PSS, participants employed the VASS for three months after a similar training period.

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Baskent University	Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight-bearing on the prosthetic side	The percentage of total body weight borne on the amputated limb will be recorded.	3 minutes
Primary	Walking capacity	"Six Minutes Walk Test" will be used to assess walking capacity. Participants will walk for 6 minutes between two points which are 24 meters apart. The total meters walked during those 6 minutes will be recorded.	6 minutes
Primary	Functional mobility	"The Timed Up and Go Test" will be used to assess functional mobility. The test starts from the seated position on the chair. With the onset of time, the participant leaves the chair, walks for 3 meters, turns 180 degrees, returns to the starting point, and sits in the chair back. The test is finished when the participant is returned to the initial position and the total time is recorded in seconds.	1 minute
Primary	Prosthetic satisfaction	"Satisfaction with Prosthesis Questionnaire" (SAT-PRO) is a self-administered questionnaire for determining the participants' satisfaction with the use of the prosthesis. It consists of 15 items. For each item, participants mark the number that best describes their satisfaction with current prosthesis (3: totally agree, 2: rather agree, 1: rather disagree, 0: totally disagree). The items 6, 12 and 14 are scored in reverse. In total, lower scores indicate higher satisfaction; the maximum score that can be taken in the questionnaire is 45 points which means 100% satisfaction and 0 points means 0% satisfaction.; The Turkish version of the SAT-PRO is a valid and reliable test that can be used to evaluate the prosthetic satisfaction of people with lower extremity amputation.	5 minutes
Primary	Body image perception	"The Amputee Body Image Scale" (ABIS) is a self-administered questionnaire for determining how an amputee perceives and feels about his/her body experience. It consists of 20 items. The items 3, 12 and 16 are scored in reverse. The total score varies from 20 to 100; lower scores indicate better body image.; The Turkish version of the ABIS was found to be valid and reliable.	5 minutes