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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria
• Intervention / Treatment: Other: Methodology of attachment of external foot prothesis

• Study Type: Observational
• Enrollment (Anticipated): 56

Contacts and Locations

• Study Contact: Name: Mark Pitkin, PhD; Phone Number: 339-364-1955; Email: Mark Pitkin <m.pitkin@yahoo.com>

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects 18-60 years old that underwent unilateral lower transtibial amputation

Description

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,

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
C1; Subjects with socket-type attachment of their prostheses	Other: Methodology of attachment of external foot prothesis; establishing the methodology of specific measurements of attachment of external foot prothesis
C2; Subjects with direct skeletal attachment	Other: Methodology of attachment of external foot prothesis; establishing the methodology of specific measurements of attachment of external foot prothesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stiffness and the index of anthropomorphicity IAm	Range of ankle stiffnesses, including three prostheses currently recommended to patients with direct skeletal attachment	30 days
IAb of the selected prosthetic feet	To establish IAb of the selected prosthetic feet via biomechanical gait testing	30 days

Collaborators and Investigators

• Sponsor: PolyOrth International

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2022
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: POI 012022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No