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

March 2, 2012 updated by: Kristen Leroy, Infoscitex Corporation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Holliston, Massachusetts, United States, 01746
      • Newton, Massachusetts, United States, 02461
        • Enrolling by invitation
        • Next Step O&P

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infoscitex Corporation

Collaborators

Liberating Technologies, Inc.
Telemedicine & Advanced Technology Research Center

Investigators

  • Principal Investigator: Kristen J LeRoy, Infoscitex Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

August 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (ESTIMATE)

March 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 2, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IST1387 PADSII
  • W81XWH-09-C-0028 (OTHER_GRANT: US Army MRMC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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