NCT04155762

Effects of Pin and Vacuum Assisted Suspension Systems

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Baskent University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputees
• Prosthesis User
• Artificial Limbs

Interventions

Type	Name	Description
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.
OTHER	Vacuum-Assisted Suspension System (a prosthetic suspension system)	After PSS, participants employed the VASS for three months after a similar training period.

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-02-01
• Completion: 2019-02-01
• First posted: 2019-11-07
• Last updated: 2019-11-12

Locations

1 site across 1 country: Turkey (Türkiye)