Bio Leg: Advancing Mobility (BAM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bio Leg.
- Who it may be relevant to
- Registry conditions: Amputation of Lower Limb Above Knee, Amputee, Amputation. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adaptive Mobility Technology: A Comparative Study of C-Leg and Bio Leg
Overview
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.
Detailed description
Although microprocessor-controlled knees (MPK) such as the C-Leg have demonstrated clear benefits over non-microprocessor-controlled prosthetic knees, it remains unclear whether powered knee assistance provides additional advantages in movement quality, metabolic efficiency, and limb loading during walking adaptability tasks.
This study directly addresses this gap by comparing mobility using the Bio Leg to mobility with the C-Leg using outcome measures that reflect real-world mobility challenges.
By generating objective evidence on whether powered knee assistance improves biomechanics, efficiency, and stability beyond that achieved with an established MPK, this study will inform prosthetic prescription, rehabilitation strategies, and payer decision-making. Given the growing population of individuals living with transfemoral amputation, identifying technologies that support safe, efficient, and confident mobility has important implications for community participation, long-term musculoskeletal health, and quality of life.
This study uses a within-subject repeated-measures design in which each participant is assessed under two conditions: current prosthesis and the Bio Leg prosthesis. All primary and secondary outcomes will be analyzed as within-participant differences, with each participant serving as their own control.
Interventions
- Device Bio Leg
After 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.
Primary outcome measures
- Change in 6-Minute Walk Test (6MWT) [Time frame: Baseline, 4-6 weeks]
- Change in Interlimb Symmetry (Ground Reaction Forces) [Time frame: Baseline, 4-6 weeks]
- Change in Metabolic Efficiency (O2/kg/m) [Time frame: Baseline, 4-6 weeks]
Eligibility criteria
Inclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brooks Rehabilitation — Jacksonville
Identifiers
NCT: NCT07613502 · IRB202600203