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NCT01559909 · ClinicalTrials.gov registry record · Phase 1
Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees
A Phase 1 study, sponsored by Stony Brook University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01559909 is a Phase 1 study that has completed, run by Stony Brook University. The registered enrollment target is 10 participants.
The verdict
NCT01559909, a Phase 1 study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01559909
The ClinicalTrials.gov registry entry for NCT01559909 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stony Brook University, which has 127 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) is the first listed.
NCT01559909 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01559909 about?
NCT01559909 is a clinical study titled "Effect of Socket Wall Height With Vacuum Suspension for Above Knee 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 ...
What is the current status of trial NCT01559909?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2012-06. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01559909?
The interventions under investigation include: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) (DEVICE).
Who is sponsoring clinical trial NCT01559909?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
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