Bio Leg: Advancing Mobility
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorUniversity of Florida
About this trial
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 (current clinical standard) to function achieved when using the Bio Leg powered micro-processor prosthetic knee.
Eligibility criteria
Qualifiers
Adults 40 to 70 years of age
Unilateral transfemoral amputation > 1 year
K3 or K4 ambulator 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bio-Leg
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Florida
Lead sponsor
Brooks Rehabilitation
Collaborator
Source ClinicalTrials.gov