NCT01546311

Evaluation of a Pro-Active Dynamic Accommodating Socket

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5 (estimated)
• Sponsor: Infoscitex Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	Pro Active Dynamic Accommodating Socket	Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-08-01
• Completion: 2012-12-01
• First posted: 2012-03-07
• Last updated: 2012-03-07

Locations

2 sites across 1 country: United States