CompletedNot Applicable

Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee

6 participantsStarted 2021-02-05

Plain-language summary

This was a prospective case series design investigation with 6 prosthesis user subjects. Subjects performed the Timed up and go (TUG) test and the two minute walk test (2MWT) along with some activities of daily living (ADL), on their prescribed knee as well as the investigational device at two separate visits. Performance was compared and statistically analyzed.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 50Kg\< body weight \< 116Kg * Cognitive ability to understand all instructions and questionnaires in the study; * K1-K2 unilateral transfemoral amputees * Allows for 37mm knee center height to dome of pyramid alignment * Age ≥ 18 years * Willing and able to participate in the study and follow the protocol * Comfortable and stable socket fit (5 or over on the SFCS) Exclusion Criteria: * Users with cognitive impairment * Users aged \<18y * Bilateral amputees * Users with stump pain affecting their functional mobility * Users with socket problems * Users with co-morbidities in the contra-lateral limb, which significantly affect their functional mobility

What they're measuring

Timed Up and Go Test (TUG Test)

Timeframe: 1 week

Trial details

NCT IDNCT04799145

SponsorÖssur Iceland ehf

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-24

Results submitted2025-10-21

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