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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05411601
Enrollment
56
Registered
2022-06-09
Start date
2022-09-30
Completion date
2024-09-30
Last updated
2022-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

OTHERMethodology of attachment of external foot prothesis

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

Sponsors

PolyOrth International
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years

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,

Design outcomes

Primary

MeasureTime frameDescription
Stiffness and the index of anthropomorphicity IAm30 daysRange of ankle stiffnesses, including three prostheses currently recommended to patients with direct skeletal attachment
IAb of the selected prosthetic feet30 daysTo establish IAb of the selected prosthetic feet via biomechanical gait testing

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026