The symposium was moderated by Prof. Dr. med. Dipl. oec Bernhard Greitemann, Medical Director and Chief Orthopedic Surgeon at Münsterland Rehabilitation Hospital in Bad Rothenfelde. He was joined by neurorehabilitation specialists from the US and Netherlands: Shane R. Wurdeman, PhD, CPO, FAAOP, from the Hanger Institute of Clinical Research and Education in Austin, TX and Dr. Bea Hemmen from Adelante Rehabilitation Center in Hoensbroek, NL, as well as Arne Schlausch, Clinical Project Manager for Ottobock.
All three speakers played important roles in the C-Brace Study Investigator Group (CBSIG), the multinational consortium behind this new research effort.
Their groundbreaking initiative was the first-ever international, randomized, multicenter KAFO study – one that ultimately spanned 14 sites in 4 countries and enrolled >100 participants using 3 different classes of orthosis. Attendees from around the world logged on to learn about the long-awaited breakthrough this study has now delivered: strong, compelling data supporting use of the C-Brace. KAFOs and stance control orthoses (SCOs) are familiar tools with well-known drawbacks, including lack of stumble recovery and limited support for reciprocal gait in "real-world" conditions (uneven terrain, slopes, stairs). In opening the symposium, Dr Wurdeman pointed out that neurorehabilitation is overdue for a meaningful expansion of orthotists' technological toolkit – and data to demonstrate patients' additional clinical meaningful benefits.
The CBSIG study aimed to address that need by directly comparing conventional KAFOs and the C-Brace. Its robust design featured multiple firsts in orthotics research: a randomized and controlled crossover design, an international patient population, a substantial sample size, and endpoints aligned with patient priorities. Analyses included both an intention-to-treat (ITT) population of 102 patients who underwent at least one data collection, and a per-protocol (PP) cohort of 69 participants who completed the study as planned.
The results, Dr. Wurdeman announced, were "dramatic" for both groups:
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Significant improvement in patient safety: The C-Brace was significantly more effective than a KAFO in reducing participants’ risk of falling (ITT: p=0.0008 vs. KAFO, PP: p=0.008 vs. KAFO). Using the C-Brace also significantly reduced the number of actual falls by a striking 78% (PP: p=0.00047 vs KAFO).
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Significant improvement in mobility: Compared with a conventional KAFO, the C-Brace significantly enhanced multiple dimensions of participants’ objective and self-reported mobility, including gait (PP: p<0.00001), ability to descend stairs (PP: p=0.006), and overall lower limb functionality (PP: p=0.00006).
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Significantly enhanced quality of life (QoL): Participants reported that the C-Brace was significantly more effective than a KAFO at improving their general health (PP: p<0.05), physical function (PP: p<0.0001), energy level (PP: p<0.01), health change (PP: p<0.001), and emotional well-being (PP: p<0.01).
As Dr. Wurdeman highlighted, these new data have great potential to advance the treatment of patients with distal limb paresis – but are only the first step for the CBSIG. Upcoming subgroup analyses may offer even more important insights on the clinical value of the C-Brace, including patient selection guidance.
Arne Schlausch, from Ottobock's Clinical Research team, addressed immediate applications of the current study data. As he pointed out, study participants’ individual results could provide a valuable "bridge to reimbursement" for future payer submissions. He offered the practical example of a participant from the Ottobock study center in Göttingen, an individual whose impressive outcomes mirrored those of the overall study. Combined with video documentation, the results of her study participation supported a successful reimbursement submission. As Arne suggested, this approach may offer a model pathway to C-Brace access. To identify appropriate patients, he pointed clinicians to the 4 sitting- and standing-related items on the Berg Balance Scale (BBS) – primary study outcomes that are also strong indicators of a C-Brace candidate. Focusing on these measurements may help lay the groundwork for both a successful product trial and a convincing reimbursement submission.
For further proof, he conducted a live demo with orthosis user Wolfgang: a patient with post-polio syndrome who had transitioned from a KAFO to the C-Brace. The difference was substantial, as Wolfgang demonstrated by performing the Timed Up-and-Go (TUG) test and BBS sit/stand units with both his previous KAFO and the C-Brace. As Wolfgang noted, "with my C-Brace, it's a different world. I don’t feel handicapped anymore. I can do everything I want to do." The approach modeled by this case report and user demo have already had a clear positive impact on other study participants' reimbursement claims in Germany. Out of 7 Göttingen participants, 6 have already received payer approval for their C-Brace.
Dr. Hemmen offered further insights from her experience with study participants at the Adelante Rehabilitation Group at Maastricht University Medical Centre. The C-Brace had helped her patients achieve impressive outcomes, but one particular individual's experience had especially interesting practical implications.
A serious accident had left this patient with significant weakness and instability in his injured limb and severely impacted his independence and autonomy. With a KAFO, he fell multiple times every week, needed support for many everyday activities, and struggled both at home and work. With the C-Brace, he experienced significant improvements in each of the study’s performance-based and self-reported parameters: Improved static and dynamic balance, reducing his fall risk and fear of falling, improved ability to pursue activities of daily living (ADLs) and dramatically increased overall well-being and happiness.
Based on this patient's outcomes, as well as her overall experience with the C-Brace, Dr Hemmen proposed a new set of selection criteria for MP-SSCO candidates: Unilateral paresis/paralysis of the lower extremity with elevated fall risk, moderate or no spasticity, no severe varus/valgus deviation, knee and/or hip flexion contracture <10° and enough hip extensor and flexor strength to control limb swing-through.
In Dr. Hemmen's view, the C-Brace could potentially have a life-changing impact on patients with these characteristics, and the CBSIG study could provide a valuable framework for identifying them – as well as steering their rehabilitation toward a positive payer response. As this groundbreaking evidence shows, the world's first and currently only MP-SSCO delivers a range of meaningful advantages over conventional KAFOs. For neurorehabilitation teams, Prof. Greitemann pointed out, the next step is clear: actively applying these findings in practice and further mining them for patient-level guidance. With payer pressure growing constantly, Dr. Wurdeman added, clinicians now need to maximize the evidence behind every recommendation – a shift that will need to be actively addressed for technologies like the C-Brace to deliver their full potential. As the speakers all agreed, there are many new worlds like Wolfgang’s waiting to take shape: they only need the right evidence to pave the way there.
REHACARE.com; Source: Ottobock SE & Co. KGaA