Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
DeviceThe brim height of the socket will be systematically reduced
NCT Number: NCT01559909
Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. To date, there is no evidence to support whether VAS alters balance, kinematics, and kinetics when walking for TF amputees as compared to conventional socket suspension technology. Further, there is question regarding what the optimal height of the socket should be to maintain stability and function. So long as stability is not sacrificed, it may be advantageous to lower the height of the socket to allow full hip motion and improve sitting comfort. The purpose of this investigation is to assess if the socket height alters the motion of the leg and changes the way one walks when using VAS compared to conventional socket suspension technology. In this study, TF amputees will be fitted with a VAS socket that will be attached to their current prosthesis using similar alignment. Individuals will be assessed while walking on a level floor and during stair negotiation while wearing the prosthesis with the VAS socket at various socket heights as well as their current socket. Additionally, balance and socket standing and sitting comfort will be investigated.
Looking for future studies?
Notify Me21 year–75 year
All sexes
Interventional
Phase 1
Stony Brook University, Stony Brook, New York, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The brim height of the socket will be systematically reduced
Time frame: 1 day
Step length, stride length, stance time, swing time, velocity
Time frame: 1 day
Time frame: 1 day
Stony Brook University
Other
Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06156839
Amputation
View Trial DetailsNCT04618406
Amputation, Cardiovascular Diseases
Aabenraa, Denmark
View Trial DetailsNCT07619963
Amputation, Paralympic Athletes
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06627361
Amputation
Multiple Locations, France
View Trial Details