Numerical Standard of Anthropomorphicity of Prosthetic Feet for Improvement of Amputee Performance

NCT ID: NCT05411601

Last Updated: 2022-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-09-30

Brief Summary

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The study concerns the testing of methodology of attachment of external foot prothesis based on anthropomorphism criteria

Detailed Description

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Conditions

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Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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C1

Subjects with socket-type attachment of their prostheses

Methodology of attachment of external foot prothesis

Intervention Type OTHER

establishing the methodology of specific measurements of attachment of external foot prothesis

C2

Subjects with direct skeletal attachment

Methodology of attachment of external foot prothesis

Intervention Type OTHER

establishing the methodology of specific measurements of attachment of external foot prothesis

Interventions

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Methodology of attachment of external foot prothesis

establishing the methodology of specific measurements of attachment of external foot prothesis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Unilateral lower transtibial amputation
* Prosthetic user with socket type attachment (Cohort 1) or with direct skeletal attachment (Cohort 2) and be able to walk 50 meters independently,
* Between 18-60 years of age,
* Able to follow instructions,
* Able to provide consent.

Exclusion Criteria

* problems on the residuum,
* Non-prosthetic user,
* Bilateral amputation,
* Self-reported pain levels greater than 4 out of 10 at study outset,
* Experienced a fall within the last 8 weeks before assessment,
* Mental illness or intellectual impairment compromising participant's ability to give informed consent,
* Injuries involving contralateral (intact) limb,
* Major uncorrected visual deficit,
* History of epilepsy or recurrent dizziness,
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PolyOrth International

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Mark Pitkin, PhD

Role: CONTACT

Other Identifiers

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POI 012022

Identifier Type: -

Identifier Source: org_study_id

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