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

Amputation Stumps Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921295
• Other study ID #: PRO16050355
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: April 28, 2017

Study information

• Verified date: April 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 28, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation Stumps

Intervention

Device:
• Sidekick Stubbies

Locations

Country	Name	City	State
United States	Bakery Square MSPO labs	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Angela DeCandia	College Park Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)