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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01559909
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : May 12, 2014
Otto Bock Healthcare Products GmbH
Information provided by (Responsible Party):
Eric Lamberg, Stony Brook University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amputation Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees
Study Start Date : June 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
Experimental: Socket wall height Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
The brim height of the socket will be systematically reduced

Primary Outcome Measures :
  1. Gait changes [ Time Frame: 1 day ]
    Step length, stride length, stance time, swing time, velocity

Secondary Outcome Measures :
  1. Comfort [ Time Frame: 1 day ]
  2. Balance [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01559909

United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794`
Long Island Orthotics and Prosthetics
West Babylon, New York, United States, 11704
Sponsors and Collaborators
Stony Brook University
Otto Bock Healthcare Products GmbH
Principal Investigator: Eric M Lamberg, EdD, PT Stony Brook University

Responsible Party: Eric Lamberg, Clinical Associate Professor, Stony Brook University Identifier: NCT01559909     History of Changes
Other Study ID Numbers: 197622
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014

Keywords provided by Eric Lamberg, Stony Brook University:
Lower limb loss
Leg amputation
walking study
socket technology