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

NCT02921295 | Completed Results

• 1 other identifier: PRO16050355
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation Stumps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Timed up and go Test Time

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

• Gait Symmetry Index

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

Study Arms (1)

Sidekick Stubbies

ACTIVE COMPARATOR

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

Interventions

Sidekick Stubbies DEVICE

Sidekick Stubbies

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angela DeCandia: lead
• College Park Industries: collaborator

Study Sites (1)

Bakery Square MSPO labs

Pittsburgh, Pennsylvania, 15206, United States

Location

Results Point of Contact

• Title: Dr. Goeran Fiedler
• Organization: University of Pittsburgh

gfiedler@pitt.edu

4126246475

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prosthetic & Orthotic Resident

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 3, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 28, 2017
• Last Updated: June 21, 2018
• Results First Posted: May 24, 2018

Record last verified: 2018-04

Locations

US (1)