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.

Study Overview

• Status: Completed
• Conditions: Amputation Stumps
• Intervention / Treatment: Device: Sidekick Stubbies

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15206
      • Bakery Square MSPO labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: Sidekick Stubbies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 times throughout study completion (every 1 hour during the 2 hour protocol)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2 times throughout study completion (every 1 hour during the 2 hour protocol)

Collaborators and Investigators

• Sponsor: Angela DeCandia
• Collaborators: College Park Industries

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): October 3, 2016

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PRO16050355