Evaluation of a Pro-Active Dynamic Accommodating Socket (PADS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Infoscitex Corporation.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Liberating Technologies, Inc
Telemedicine and Advanced Technology Research Center (TATRC)
Information provided by (Responsible Party):
Kristen Leroy, Infoscitex Corporation
ClinicalTrials.gov Identifier:
NCT01546311
First received: March 2, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 2, 2012
March 2, 2012
January 2012
August 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of a Pro-Active Dynamic Accommodating Socket
Not Provided

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
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.

Amputation
Device: Pro Active Dynamic Accommodating Socket
Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb
lower limb amputees
Intervention: Device: Pro Active Dynamic Accommodating Socket
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
December 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
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
 
NCT01546311
IST1387 PADSII, W81XWH-09-C-0028
Not Provided
Kristen Leroy, Infoscitex Corporation
Infoscitex Corporation
  • Liberating Technologies, Inc
  • Telemedicine and Advanced Technology Research Center (TATRC)
Principal Investigator: Kristen J LeRoy Infoscitex Corporation
Infoscitex Corporation
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP