An interventional study of Pin Suspension System (a prosthetic suspension system) and Vacuum-Assisted Suspension System (a prosthetic suspension system) in Amputees, Prosthesis User and Artificial Limbs, sponsored by Baskent University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Baskent University · Not applicable, Interventional, and Other
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.
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Exclusion Criteria:
Both suspension systems were applied consecutively to the participants. Initially, participants used the Pin Suspension System (PSS) for three months following fabrication and adjustment of the prosthesis, and a prosthetic training period. They then employed the Vacuum-Assisted Suspension System (VASS) for three months after a similar training period.
Other: Pin Suspension System (a prosthetic suspension system) · Other: Vacuum-Assisted 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.
After PSS, participants employed the VASS for three months after a similar training period.
Weight-bearing on the prosthetic side
The percentage of total body weight borne on the amputated limb will be recorded.
Time frame: 3 minutes
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.
Time frame: 6 minutes
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.
Time frame: 1 minute
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.
Time frame: 5 minutes
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.
Time frame: 5 minutes
Plan to share: No
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Baskent University