A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-04-28

Brief Summary

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The purpose of this study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.

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Detailed Description

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Conditions

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Amputation Stumps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Sidekick Stubbies

Conventional Stubby prostheses were used for baseline measures. In the sequential crossover design, articulated stubby prostheses ("Sidekick" manufactured by College Park Ind.) were used as intervention

Group Type ACTIVE_COMPARATOR

Sidekick Stubbies

Intervention Type DEVICE

Interventions

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Sidekick Stubbies

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* bilateral transfemoral amputee
* own a pair of conventional stubby prosthesis with standard adaptation

Exclusion Criteria

* dependence on assistive walking device or wheelchair (may use devices occasionally but should be able to ambulate without them)
* use of prosthesis that do not allow change of feet with standard adapters
* any medical condition that may put an individual in greater risk of injury than normal daily activity.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes