BionicM and Brooks Rehabilitation Launch Clinical Study Comparing Powered Bio Leg to Microprocessor Knees

BionicM USA LLC and Brooks Rehabilitation have announced a collaborative clinical research study, titled Adaptive Mobility Technology: A Comparative Study of Bio Leg and C-Leg, focused on evaluating functional mobility outcomes associated with the Bio Leg powered prosthetic knee.

The study brings together clinical, research and engineering expertise from both organizations to examine how powered knee technology may support individuals with transfemoral (above-knee) amputation as they navigate real-world mobility tasks. Bio Leg, BionicM’s powered microprocessor knee, evaluated in collaboration with Brooks Rehabilitation to assess real-world mobility and stability.

Study rationale

Following a transfemoral amputation, many individuals experience persistent mobility limitations unless on level ground. Activities such as climbing ramps, moving across uneven ground and transitioning between sitting and standing often require compensatory movement strategies. These adjustments can increase physical effort, reduce efficiency and may lead to fatigue, making it harder to stay active and engaged in daily life.

While microprocessor-controlled knees have advanced stability and safety, powered prosthetic technology, like the Bio Leg, has the potential to provide active assistance during demanding mobility tasks. This study aims to generate objective data to better understand how powered knee assistance may influence movement quality, efficiency, and enhance the overall user experience.

Study overview

This exploratory pilot study will evaluate functional mobility using the Bio Leg compared to participants’ current microprocessor-controlled prosthetic knees. Outcomes will be assessed using a combination of clinical testing, biomechanical analysis and patient-reported measures to capture multiple dimensions of mobility performance and user experience.

Testing will be conducted at Brooks Rehabilitation, including within the Brooks Motion Analysis Center, utilizing established assessment methodologies and research infrastructure.

Study design and leadership team

The study is being conducted by an interdisciplinary leadership team at Brooks Rehabilitation that includes physical therapists, physicians, biomechanical researchers and clinical specialists with expertise in amputee rehabilitation and mobility research, alongside perspectives informed by individuals with transfemoral amputation who utilize prosthetic knee technology in daily life.

The research is led by Principal Investigator Emily J. Fox, PhD, DPT, MHS, director of neuromuscular research at Brooks Rehabilitation and the Brooks Motion Analysis Center, with clinical leadership and collaboration from Howard Weiss, DO, medical director of the Amputee Program at Brooks Rehabilitation.

The study utilizes a within-subject comparative design involving adults with unilateral transfemoral amputation who will complete assessments using their current prosthesis followed by evaluation after acclimation to the Bio Leg device.

“This study reflects a collaborative effort to rigorously evaluate powered prosthetic knee technology using established clinical and biomechanical methods,” said Emily J. Fox, PhD, DPT, MHS. “Our goal is to generate high-quality data that can inform clinicians, researchers and individuals with limb loss.”

“In my clinical experience, the Bio Leg has demonstrated promising outcomes and a level of intuitive use that is unique among prosthetic knee technologies. This study is an important step toward objectively evaluating its impact on mobility, endurance and functional performance in individuals with transfemoral amputation,” said Howard Weiss, DO.

The results of the study will be analyzed and shared through scientific and clinical channels once data collection is complete.

About BionicM USA LLC

Founded in 2018 as a spin-off from the University of Tokyo, BionicM emerged from the innovative research and development spearheaded by Sunny Xiaojun Sun during his doctoral studies at the University of Tokyo, under the mentorship of Professor Inaba (currently Professor Emeritus). Supported by JST’s START program, BionicM leverages advanced humanoid robotics technology to develop and market powered microprocessor knees. As a global startup, BionicM is driven by its mission to “Power Mobility for All,” with a focus on enhancing mobility and improving the quality of life (QOL) for individuals with lower-limb amputations. Through cutting-edge technology and a commitment to innovation, BionicM aims to provide transformative solutions that empower users to lead more active and fulfilling lives. BionicM USA LLC is the USA Headquarters located in Ashburn, VA.