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

This study has been completed.
Sponsor:
Collaborator:
Otto Bock Healthcare Products GmbH
Information provided by (Responsible Party):
Eric Lamberg, Stony Brook University
ClinicalTrials.gov Identifier:
NCT01559909
First received: August 16, 2011
Last updated: May 8, 2014
Last verified: May 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Stony Brook University:

Primary Outcome Measures:
  • Gait changes [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Step length, stride length, stance time, swing time, velocity


Secondary Outcome Measures:
  • Comfort [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Balance [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eric Lamberg, Clinical Associate Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT01559909     History of Changes
Other Study ID Numbers: 197622
Study First Received: August 16, 2011
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014