Evaluation of a Pro-Active Dynamic Accommodating Socket (PADS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Amputation |
Device: Pro Active Dynamic Accommodating Socket |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Estimated Enrollment: | 5 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| lower limb amputees |
Device: Pro Active Dynamic Accommodating Socket
Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Persons with transfemoral or transtibial amputation who have been using a prosthesis for at least one month will be recruited for this study.
Inclusion Criteria:
- transfemoral or transtibial amputation
- unilateral or bilateral amputation
- stable residual limb volume
- read, write, and speak English for proper consent and responding to questionnaire
Exclusion Criteria:
- evidence or history of residual limb skin conditions such as irritation or sores
- presence of phantom limb pain
Contacts and Locations| Contact: Elizabeth Klodd | 508-893-6363 ext 23 | liz.klodd@liberatingtech.com |
| Contact: Kristen LeRoy | 781-890-1338 ext 234 | kleroy@infoscitex.com |
| United States, Massachusetts | |
| Liberating Technologies, Inc | Recruiting |
| Holliston, Massachusetts, United States, 01746 | |
| Contact: Elizabeth Klodd 508-893-6363 ext 23 liz.klodd@liberatingtech.com | |
| Next Step O&P | Enrolling by invitation |
| Newton, Massachusetts, United States, 02461 | |
| Principal Investigator: | Kristen J LeRoy | Infoscitex Corporation |
More Information
No publications provided
| Responsible Party: | Kristen Leroy, Group Leader, Biomedical Devices, Infoscitex Corporation |
| ClinicalTrials.gov Identifier: | NCT01546311 History of Changes |
| Other Study ID Numbers: | IST1387 PADSII, W81XWH-09-C-0028 |
| Study First Received: | March 2, 2012 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Infoscitex Corporation:
|
prosthetic socket residual limb volume fluctuation instantaneous bladder |
ClinicalTrials.gov processed this record on May 16, 2013