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

NCT01559909 | Completed Phase 1

• 1 other identifier: 197622
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Amputation

Keywords

Lower limb loss; Leg amputation; walking study; socket technology

Outcome Measures

Primary Outcomes (1)

• Gait changes

  Step length, stride length, stance time, swing time, velocity

  1 day

Secondary Outcomes (2)

• Comfort

  1 day

• Balance

  1 day

Study Arms (1)

Socket wall height

EXPERIMENTAL

Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)

Interventions

Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) DEVICE

The brim height of the socket will be systematically reduced

Socket wall height

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead
• Otto Bock Healthcare Products GmbH: collaborator

Study Sites (2)

Stony Brook University

Stony Brook, New York, 11794', United States

Location

Long Island Orthotics and Prosthetics

West Babylon, New York, 11704, United States

Location

Study Officials

• Eric M Lamberg, EdD, PT

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: March 21, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

US (2)