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.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794'
      • Stony Brook University
    • West Babylon, New York, United States, 11704
      • Long Island Orthotics and Prosthetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait changes	Step length, stride length, stance time, swing time, velocity	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Comfort	1 day
Balance	1 day

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: Otto Bock Healthcare Products GmbH
• Investigators: Principal Investigator: Eric M Lamberg, EdD, PT, Stony Brook University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 16, 2011
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 21, 2012

Study Record Updates

• Last Update Posted (Estimate): May 12, 2014
• Last Update Submitted That Met QC Criteria: May 8, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Lower limb loss; Leg amputation; walking study; socket technology
• Other Study ID Numbers: 197622