Bio Leg: Advancing Mobility (BAM)
Trial statusRecruiting
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 (micro-processor controlled prosthetic knee; current clinical standard) to function achieved when using the Bio Leg powered micro-processor prosthetic knee.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults 40 to 70 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
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
Design model
Crossover
Treatments tested in this trial
Bio Leg
DeviceAfter completing biomechanics and clinical testing at Pre Assessment with their C-Leg, participants will be fitted with a Bio-Leg prosthesis at the prosthetist clinic. The participant will train and use the Bio-Leg prosthesis during a 4-6 week acclimation period. The participant will then complete the same biomechanics and clinical testing at Post Assessment.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: C-LegNo intervention 0 interventions
Group B: Bio LegExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in 6-Minute Walk Test (6MWT)
The distance that a patient should walk based on their height, weight, age, and gender. Performance assessment of walking endurance for 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.
Time frame
Baseline, 4-6 weeks2
Change in Interlimb Symmetry (Ground Reaction Forces)
A direct measure of vertical ground reaction forces during the rising phase of a sit-to-stand task (measured in Newtons) using standard force plates embedded in the floor. Increased symmetry in ground reaction forces between the lower limbs reflects improved equalization of weight distribution between the limbs.
Time frame
Baseline, 4-6 weeks3
Change in Metabolic Efficiency (O2/kg/m)
A direct measure assessed during the six-minute walk test. Metabolic efficiency is determined by the energy cost of transport, defined as oxygen consumption per unit body weight and distance walked (O₂/kg/m), which accounts for the individual's weight and walking speed. Improved metabolic efficiency reflects enhanced oxygen delivery and utilization during walking.
Time frame
Baseline, 4-6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
Brooks Rehabilitation
Collaborator
Source ClinicalTrials.gov