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

Study Overview
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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.

Official Title
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Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees

Conditions
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Amputation

Intervention / Treatment
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* Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Socket wall height<br> | Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)<br>* The brim height of the socket will be systematically reduced<br>|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort |  | 1 day | 
| Balance |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower limb loss, Leg amputation, walking study, socket technology