Status:
UNKNOWN
Numerical Standard of Anthropomorphicity of Prosthetic Feet for Improvement of Amputee Performance
Lead Sponsor:
PolyOrth International
Conditions:
Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria
Eligibility:
All Genders
18-60 years
Brief Summary
The study concerns the testing of methodology of attachment of external foot prothesis based on anthropomorphism criteria
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
September 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05411601
Start Date
September 30 2022
End Date
September 30 2024
Last Update
June 9 2022
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