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

August 16, 2011
May 8, 2014
June 2012
December 2013   (final data collection date for primary outcome measure)
Gait changes [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Step length, stride length, stance time, swing time, velocity
Same as current
Complete list of historical versions of study NCT01559909 on ClinicalTrials.gov Archive Site
  • Comfort [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Balance [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees
Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral 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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Amputation
Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
The brim height of the socket will be systematically reduced
Experimental: Socket wall height
Intervention: Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01559909
197622
No
Eric Lamberg, Stony Brook University
Stony Brook University
Otto Bock Healthcare Products GmbH
Principal Investigator: Eric M Lamberg, EdD, PT Stony Brook University
Stony Brook University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP