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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Socket wall height

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

The brim height of the socket will be systematically reduced

Interventions

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

The brim height of the socket will be systematically reduced

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No