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

Infoscitex

Status: Unknown

Conditions: Amputation

Treatments: Device: Pro Active Dynamic Accommodating Socket

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01546311

IST1387 PADSII

W81XWH-09-C-0028 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 1 patient group

lower limb amputees

Treatment:

Device: Pro Active Dynamic Accommodating Socket