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

NCT05411601 | Unknown

• 1 other identifier: POI 012022
• Study Type: observational
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

C1

Subjects with socket-type attachment of their prostheses

Other: Methodology of attachment of external foot prothesis

C2

Subjects with direct skeletal attachment

Other: Methodology of attachment of external foot prothesis

Interventions

Methodology of attachment of external foot prothesis OTHER

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

C1; C2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• PolyOrth International: lead

Central Study Contacts

Mark Pitkin, PhD

CONTACT

339-364-1955; Mark Pitkin <m.pitkin@yahoo.com>

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: September 30, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share