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Completed

NCT Number: NCT02921295

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

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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Key information

Conditions

Amputation Stumps

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakery Square MSPO labs

Pittsburgh, Pennsylvania, 15206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sidekick Stubbies

Device

Primary outcomes

  1. Average Speed for 10 Meter Walk Test

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

    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.

Secondary outcomes

  1. Timed up and go Test Time

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

    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.

  2. Gait Symmetry Index

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

    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.

Sponsors and collaborators

Lead sponsor

Angela DeCandia

Other

Collaborators

  • College Park Industries

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2016
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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