Amputee Residual Limb Volume Fluctuation

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

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-09-30

Brief Summary

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The goal of this project is a useful clinical instrument for diagnosis and treatment of residual limb volume fluctuation in individuals who use prosthetic limbs. One hypothesis to be tested is that the instrument effectively measures short and long term volume fluctuations in individuals with trans-tibial amputation. Another hypothesis to be tested is that when subjects add a sock or insert to the prosthesis residual limb volume decreases, and when they remove the sock or insert residual limb volume increases.

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Detailed Description

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Conditions

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Amputation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lower-limb amputee

Subjects with at least one lower limb amputated at the trans-tibial level

Monitored for limb volume

Intervention Type OTHER

Subjects are monitored for limb volume change using bioimpedance analysis

Interventions

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Monitored for limb volume

Subjects are monitored for limb volume change using bioimpedance analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* trans-tibial amputees who have a regular prosthetist and who wear the prosthesis at least five hours per day.

Exclusion Criteria

* Inability to ambulate continuously with a prosthesis (with or without the use of an assistive device such as a cane or walker) for 10 minutes indoors on a level walkway. 2. Inability to shift from horizontal to vertical posture in 30 seconds.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes