Evaluation of a Pro-Active Dynamic Accommodating Socket

Amputation Clinical Trial

— PADS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01546311
• Other study ID #: IST1387 PADSII
• Secondary ID: W81XWH-09-C-0028
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2012
• Last updated: March 2, 2012
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Infoscitex Corporation
• Contact: Elizabeth Klodd
• Phone: 508-893-6363
• Email: liz.klodd[@]liberatingtech.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Pro Active Dynamic Accommodating Socket
Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb

Locations

Country	Name	City	State
United States	Liberating Technologies, Inc	Holliston	Massachusetts
United States	Next Step O&P	Newton	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Infoscitex Corporation	Liberating Technologies, Inc, Telemedicine & Advanced Technology Research Center

Country where clinical trial is conducted

United States,