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OpenTrials
Completed

NCT Number: NCT01559909

Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees

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.

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Key information

Conditions

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stony Brook University, Stony Brook, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female between the ages of 21 and 75 with a transfemoral amputation.
  • Limited household ambulators (K1) to those considered unlimited community ambulators (K4).
  • People who are comfortably fitted with a prosthesis for at least 6 months.

Exclusion criteria

  • People with severe cardiac or pulmonary disease that limits ability to walk.
  • People with too much discomfort and/or pain.
  • People with active wounds on their residual limb or other foot.

Treatment and study plan

Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)

Device

The brim height of the socket will be systematically reduced

Primary outcomes

  1. Gait changes

    Time frame: 1 day

    Step length, stride length, stance time, swing time, velocity

Secondary outcomes

  1. Comfort

    Time frame: 1 day

  2. Balance

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • Otto Bock Healthcare Products GmbH

Registry information

Official study title

Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2012
Registry last updated
May 12, 2014

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.

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