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Bio Leg: Advancing Mobility (BAM)

RecruitingNAAges 40 Years - 80 YearsAllUniversity of Florida
NCT07613502 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Following transfemoral amputation, regaining functional mobility, particularly the ability to navigate curbs, ramps, long distances, and the ability to stand is challenging and often unattainable. Use of advanced prosthetic limb technology can dramatically influence mobility outcomes. The purpose of this study is to compare walking function in individuals with transfemoral amputations who are current users of the C-leg (micro-processor controlled prosthetic knee; current clinical standard) to function achieved when using the Bio Leg powered micro-processor prosthetic knee.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults 40 to 80 years of age * Unilateral transfemoral amputation \> 1 year * K3 or K4 ambulator (based on the K classification system) and able to walk with no greater assistances than a single point cane * Current microprocessor-controlled prosthesis (C-leg) user with \> 6 months experience and able to walk without a device of using a single point cane * Able to give informed consent Exclusion Criteria: * Severe cardiovascular condition or other disease limiting study participation * Skin lesions or wounds, acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking activities * Residual limb dysfunction (i.e. joint contracture) limiting mobility or study participation * Pain that limits walking of participation in walking activities * Current participation in rehabilitation to address walking function
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What it tests

  • Bio Leg
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Where

1 site
Brooks Rehabilitation
Jacksonville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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