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Not Yet Recruiting NCT05628064

1C70 Feasibility Study

Conditions: Amputation

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: Otto Bock Healthcare Products GmbH

Location: Germany

Summary

The objective of this study is to characterize the extend of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain.

Eligibility Criteria

Inclusion Criteria:Person is at least 18 years old.Person is a unilateral transtibial amputee with stabilized residual limb.Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL) .Person has at least 6 months experience in walking with a prosthesis.Person is using an energy storage and return (ESR) foot as their primary everyday footPerson has a foot size between 22 and 30.Person weights with a prosthesis between 50 and 125 kg (foot size 26 - 30), or between 45 and 100 kg (foot size 22 - 25).Person wears a prosthesis daily and ≥ 8 hours/day.Person is able to walk at least 500 m without having to make a break.Person is willing and able to independently provide informed consent.Person is willing to comply with study procedures.Exclusion Criteria:Person is pregnant.Person is using a hydraulic foot as their primary everyday foot.Person is using a sport foot (e.g., Fillauer AllPro, Ottobock Challenger, Össur Flex-Foot Cheetah) as their primary everyday foot.Person is using an ESR foot with an integrated vacuum pump (e.g., Ottobock 1C62 Triton Harmony).Person has conditions that would prevent participation and pose increased risk (e.g., unstable cardiovascular conditions that preclude physical activity such as walking).Person falls ≥ once a week due to the reasons that are not related to prosthesis (e.g., problems with vestibular system).Person is not available for study visits during planned study duration.Person is participating in another study or intends to participate in another study during this study´s duration.Person cannot personally provide their consent.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05628064). StuddyBuddy aggregates publicly available trial information.