Effects of Pin and Vacuum Assisted Suspension Systems

NCT ID: NCT04155762

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2019-02-01

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.

Conditions

Amputees; Prosthesis User; Artificial Limbs

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Pin Suspension System (a prosthetic suspension system)

Intervention Type: OTHER

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)

Intervention Type: OTHER

After PSS, participants employed the VASS for three months after a similar training period.

Interventions

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.

Intervention Type: OTHER

Vacuum-Assisted Suspension System (a prosthetic suspension system)

After PSS, participants employed the VASS for three months after a similar training period.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: collaborator

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Senay Cerezci Duygu

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatih Erbahceci, Prof

Role: STUDY_CHAIR

Hacettepe University

Bahar Kulunkoglu, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Yildirim Beyazit University

Senay Cerezci Duygu, MsC

Role: STUDY_DIRECTOR

Baskent University

Locations

Baskent University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GO 15/123

Identifier Type: -

Identifier Source: org_study_id