Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amputation |
Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees |
- Gait changes [ Time Frame: 1 day ] [ Designated as safety issue: No ]Step length, stride length, stance time, swing time, velocity
- Comfort [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Balance [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Socket wall height |
Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
The brim height of the socket will be systematically reduced
|
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Eric M Lamberg, EdD, PT | 631-444-3058 | eric.lamberg@stonybrook.edu |
| United States, New York | |
| Stony Brook University | Recruiting |
| Stony Brook, New York, United States, 11794` | |
| Contact: Eric M Lamberg | |
| Long Island Orthotics and Prosthetics | Recruiting |
| West Babylon, New York, United States, 11704 | |
| Principal Investigator: | Eric M Lamberg, EdD, PT | Stony Brook University |
More Information
No publications provided
| Responsible Party: | Eric Lamberg, Clinical Associate Professor, Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT01559909 History of Changes |
| Other Study ID Numbers: | 197622 |
| Study First Received: | August 16, 2011 |
| Last Updated: | January 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Stony Brook University:
|
Lower limb loss Leg amputation walking study socket technology |
ClinicalTrials.gov processed this record on May 19, 2013