Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees
| Tracking Information | |||||
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| First Received Date ICMJE | August 16, 2011 | ||||
| Last Updated Date | January 8, 2013 | ||||
| Start Date ICMJE | June 2012 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Gait changes [ Time Frame: 1 day ] [ Designated as safety issue: No ] Step length, stride length, stance time, swing time, velocity |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01559909 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees | ||||
| Official Title ICMJE | Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Amputation | ||||
| Intervention ICMJE | Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
The brim height of the socket will be systematically reduced |
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| Study Arm (s) | Experimental: Socket wall height
Intervention: Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01559909 | ||||
| Other Study ID Numbers ICMJE | 197622 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Eric Lamberg, Stony Brook University | ||||
| Study Sponsor ICMJE | Stony Brook University | ||||
| Collaborators ICMJE | Otto Bock Healthcare Products GmbH | ||||
| Investigators ICMJE |
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| Information Provided By | Stony Brook University | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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