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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559909
First Posted: March 21, 2012
Last Update Posted: May 12, 2014
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.
Collaborator:
Otto Bock Healthcare Products GmbH
Information provided by (Responsible Party):
Eric Lamberg, Stony Brook University
  Purpose
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 Intervention Phase
Amputation Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eric Lamberg, Stony Brook University:

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


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

Estimated Enrollment: 10
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Socket wall height Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
The brim height of the socket will be systematically reduced

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01559909


Locations
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
Investigators
Principal Investigator: Eric M Lamberg, EdD, PT Stony Brook University
  More Information

Responsible Party: Eric Lamberg, Clinical Associate Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT01559909     History of Changes
Other Study ID Numbers: 197622
First Submitted: August 16, 2011
First Posted: March 21, 2012
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


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