Influence of Socket Volume on Prosthesis Performance

NCT ID: NCT02124915

Last Updated: 2017-08-24

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

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis use, perceived comfort, and satisfaction with the prosthesis are affected by size of the prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again after wearing a slightly oversized socket for 1 month.

Detailed Description

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Conditions

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Lower Limb Amputation Below Knee (Injury)

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Transtibial amputees

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* transtibial amputee
* at least 18 months post amputation
* over 18 years of age
* capable of treadmill walking and 90 seconds of continuous standing

Exclusion Criteria

* skin breakdown on the residual limb
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Joan Sanders

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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R01HD069387

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001507

Identifier Type: -

Identifier Source: org_study_id

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