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Recruiting NCT07613502

Bio Leg: Advancing Mobility (BAM)

Conditions: Amputation of Lower Limb Above Knee, Amputee, Amputation

Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: University of Florida

Location: Brooks Rehabilitation Jacksonville Florida

Summary

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07613502). StuddyBuddy aggregates publicly available trial information.