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

Not yet recruiting

• Conditions: Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria
• Interventions: Other: Methodology of attachment of external foot prothesis

• Registration Number: NCT05411601
• Lead Sponsor: PolyOrth International

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Last Update Submitted: 2022-06-06
• Study First Posted: 2022-06-09
• Last Update Posted: 2022-06-09
• Study Start: 2022-09-30
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C1	Methodology of attachment of external foot prothesis	Subjects with socket-type attachment of their prostheses
C2	Methodology of attachment of external foot prothesis	Subjects with direct skeletal attachment

Primary Outcome Measures

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