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Status unknownNCT05411601Updated Jun 9, 2022

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

An observational study in Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria, sponsored by PolyOrth International. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by PolyOrth International · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria
03

In context

Lead sponsor

PolyOrth International is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

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,
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherMethodology of attachment of external foot prothesis

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

06

What researchers measure

Primary outcomes

  1. Stiffness and the index of anthropomorphicity IAm

    Range of ankle stiffnesses, including three prostheses currently recommended to patients with direct skeletal attachment

    Time frame: 30 days

  2. IAb of the selected prosthetic feet

    To establish IAb of the selected prosthetic feet via biomechanical gait testing

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05411601
Lead sponsor
PolyOrth International
Responsible party
Sponsor
First posted
Jun 9, 2022
Start date
Sep 30, 2022 (estimated)
Primary completion
Sep 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Jun 9, 2022

Study contacts

Mark Pitkin, PhD
Contact
Mark Pitkin <m.pitkin@yahoo.com>
339-364-1955

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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