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

A

Angela DeCandia

Status

Completed

Conditions

Amputation Stumps

Treatments

Device: Sidekick Stubbies

Study type

Interventional

Funder types

Other

Identifiers

NCT02921295
PRO16050355

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

1 participants in 1 patient group

Sidekick Stubbies
Active Comparator group
Description:
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
Treatment:
Device: Sidekick Stubbies

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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