Skip to content

Evaluation of a Pro-Active Dynamic Accommodating Socket

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01546311
Acronym
PADS
Enrollment
5
Registered
2012-03-07
Start date
2012-01-31
Completion date
2012-12-31
Last updated
2012-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation

Keywords

prosthetic socket, residual limb volume fluctuation, instantaneous bladder

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.

Interventions

DEVICEPro Active Dynamic Accommodating Socket

Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb

Sponsors

Liberating Technologies, Inc.
CollaboratorINDUSTRY
Telemedicine & Advanced Technology Research Center
CollaboratorOTHER
Infoscitex Corporation
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Countries

United States

Contacts

Primary ContactElizabeth Klodd
liz.klodd@liberatingtech.com508-893-6363
Backup ContactKristen LeRoy
kleroy@infoscitex.com781-890-1338

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026