Clinical trial NCT04155762: Effects of Pin and Vacuum Assisted Suspension Systems
Official title: A Comparison of the Effects of Pin and Vacuum Assisted Suspension Systems in Transtibial Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputees
Prosthesis User
Artificial Limbs
Keywords: Amputees
Artificial Limbs
Prosthetic designs
Rehabilitation of prostheses users
Prosthetic suspension systems
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2019-11-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weight-bearing on the prosthetic side
timeFrame: 3 minutes
measure: Walking capacity
timeFrame: 6 minutes
measure: Functional mobility
timeFrame: 1 minute
measure: Prosthetic satisfaction
timeFrame: 5 minutes
measure: Body image perception
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
affiliation: Hacettepe University
name: Fatih Erbahceci, Prof
role: STUDY_CHAIR
affiliation: Yildirim Beyazit University
name: Bahar Kulunkoglu, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Baskent University
name: Senay Cerezci Duygu, MsC
role: STUDY_DIRECTOR
References: