Evaluation of a Pro-Active Dynamic Accommodating Socket

• Conditions: Amputation
• Interventions: Device: Pro Active Dynamic Accommodating Socket

• Registration Number: NCT01546311
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01
• Status Verified: 2012-03
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-02
• Last Update Submitted: 2012-03-02
• Study First Posted: 2012-03-07
• Last Update Posted: 2012-03-07
• Primary Completion: 2012-08
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lower limb amputees	Pro Active Dynamic Accommodating Socket	-

Trial Locations

Locations (2)

Liberating Technologies, Inc; 🇺🇸 Holliston, Massachusetts, United States

Next Step O&P; 🇺🇸 Newton, Massachusetts, United States