Evaluation of a Pro-Active Dynamic Accommodating Socket

NCT ID: NCT01546311

Last Updated: 2012-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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

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Amputation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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lower limb amputees

Pro Active Dynamic Accommodating Socket

Intervention Type DEVICE

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

Interventions

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Pro Active Dynamic Accommodating Socket

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liberating Technologies, Inc.

INDUSTRY

Sponsor Role collaborator

Telemedicine & Advanced Technology Research Center

OTHER

Sponsor Role collaborator

Infoscitex Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Kristen Leroy

Group Leader, Biomedical Devices

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristen J LeRoy

Role: PRINCIPAL_INVESTIGATOR

Infoscitex Corporation

Locations

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Liberating Technologies, Inc

Holliston, Massachusetts, United States

Site Status RECRUITING

Next Step O&P

Newton, Massachusetts, United States

Site Status ENROLLING_BY_INVITATION

Countries

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United States

Central Contacts

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Elizabeth Klodd

Role: CONTACT

508-893-6363 ext. 23

Kristen LeRoy

Role: CONTACT

781-890-1338 ext. 234

Facility Contacts

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Elizabeth Klodd

Role: primary

508-893-6363 ext. 23

Other Identifiers

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W81XWH-09-C-0028

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IST1387 PADSII

Identifier Type: -

Identifier Source: org_study_id

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