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 & Advanced Technology Research Center
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
  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

Resource links provided by NLM:


Further study details as provided by Infoscitex Corporation:

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
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546311

Contacts
Contact: Elizabeth Klodd 508-893-6363 ext 23 liz.klodd@liberatingtech.com
Contact: Kristen LeRoy 781-890-1338 ext 234 kleroy@infoscitex.com

Locations
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
Sponsors and Collaborators
Infoscitex Corporation
Liberating Technologies, Inc
Telemedicine & Advanced Technology Research Center
Investigators
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 August 28, 2014