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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01546311
Recruitment Status : Unknown
Verified March 2012 by Kristen Leroy, Infoscitex Corporation.
Recruitment status was:  Recruiting
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
Liberating Technologies, Inc
Telemedicine & Advanced Technology Research Center
Information provided by (Responsible Party):
Kristen Leroy, Infoscitex Corporation

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.

Condition or disease Intervention/treatment
Amputation Device: Pro Active Dynamic Accommodating Socket

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.

Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Study Start Date : January 2012
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : December 2012

Group/Cohort Intervention/treatment
lower limb amputees Device: Pro Active Dynamic Accommodating Socket
Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01546311

Contact: Elizabeth Klodd 508-893-6363 ext 23
Contact: Kristen LeRoy 781-890-1338 ext 234

United States, Massachusetts
Liberating Technologies, Inc Recruiting
Holliston, Massachusetts, United States, 01746
Contact: Elizabeth Klodd    508-893-6363 ext 23   
Next Step O&P Enrolling by invitation
Newton, Massachusetts, United States, 02461
Sponsors and Collaborators
Infoscitex Corporation
Liberating Technologies, Inc
Telemedicine & Advanced Technology Research Center
Principal Investigator: Kristen J LeRoy Infoscitex Corporation

Responsible Party: Kristen Leroy, Group Leader, Biomedical Devices, Infoscitex Corporation Identifier: NCT01546311     History of Changes
Other Study ID Numbers: IST1387 PADSII
W81XWH-09-C-0028 ( Other Grant/Funding Number: US Army MRMC )
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Kristen Leroy, Infoscitex Corporation:
prosthetic socket
residual limb volume fluctuation
instantaneous bladder