Evaluation of a Pro-Active Dynamic Accommodating Socket (PADS)
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| First Received Date ICMJE | March 2, 2012 | ||||||||
| Last Updated Date | March 2, 2012 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of a Pro-Active Dynamic Accommodating Socket | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | The primary objective of this study is to assess the effectiveness of the pro-active dynamic socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees during ambulation and rest, addressing residual limb volume fluctuations with a controlled flow bladder system. |
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| Detailed Description | The purpose of this study is to compare a pro-active dynamic socket to each user's everyday ischial containment socket in above-knee amputees, or transtibial socket in below-knee amputees. It is the goal for the pro-active dynamic socket to alleviate high pressure on the residual limb and improve socket fit and comfort. The pro-active dynamic socket contains bladders that can inflate and deflate throughout the gait cycle to appropriate levels of pressure to improve socket fit. These improvements will be confirmed by pressure measurements on the distal end of the residual limb, the ischium, and the bladders located around the socket walls. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Persons with transfemoral or transtibial amputation who have been using a prosthesis for at least one month will be recruited for this study. |
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| Condition ICMJE | Amputation | ||||||||
| Intervention ICMJE | Device: Pro Active Dynamic Accommodating Socket
Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb |
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| Study Group/Cohort (s) | lower limb amputees
Intervention: Device: Pro Active Dynamic Accommodating Socket |
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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 | 5 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01546311 | ||||||||
| Other Study ID Numbers ICMJE | IST1387 PADSII, W81XWH-09-C-0028 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Kristen Leroy, Infoscitex Corporation | ||||||||
| Study Sponsor ICMJE | Infoscitex Corporation | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Infoscitex Corporation | ||||||||
| Verification Date | March 2012 | ||||||||
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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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