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

PolyOrth

Status: Not yet enrolling

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

Treatments: Other: Methodology of attachment of external foot prothesis

Study type: Observational

Funder types: Industry

Identifiers

NCT05411601

POI 012022

Details and patient eligibility

About

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

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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,

Trial design

56 participants in 2 patient groups

C1

Description:

Subjects with socket-type attachment of their prostheses

Treatment:

Other: Methodology of attachment of external foot prothesis

C2

Description:

Subjects with direct skeletal attachment

Treatment:

Other: Methodology of attachment of external foot prothesis