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

Angela DeCandia1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Amputation Stumps

Interventions

Sidekick StubbiesDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Bakery Square MSPO labs

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Average Speed for 10 Meter Walk Test

The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.

Time frame: 2 times throughout study completion (every 1 hour during the 2 hour protocol)

Secondary Outcomes

Timed up and go Test Time

The test, as described in the protocol form, is performed three times with each intervention. This allows averaging to reduce the risk of random errors in timing the exercise. Accordingly, the participant is asked to repeat (with resting breaks in between) the tests three times with the stubbies and three times with the sidekicks.

Time frame: 6 times throughout study completion (3 every 1 hour during the 2 hour protocol)

Gait Symmetry Index

Left/Right Step Duration Ratio. Perfect gait symmetry would result in a ratio of 1.000. Any deviation would indicate that step lengths differ between legs, indicating a more or less pronounced limping. The measure is computed from the intermediary step sample of gait with each intervention. This allows averaging to reduce the risk of random errors in assessment. Step samples were extracted from walking trial data with the stubbies and with the sidekicks. Each walking trial contains more than 30 individual steps for analysis.

Time frame: 2 times throughout study completion (every 1 hour during the 2 hour protocol)

Data from ClinicalTrials.gov

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