Bionik Laboratories, Inc., a global pioneering robotics company focused on providing rehabilitation solutions to individuals with neurological disorders, announced today that the study led by Newcastle University under the auspices of the National Institute for Health Research (NIHR) HTA Programme has achieved 50 percent enrollment for its multicenter, randomized controlled RATULS trial.
The National Institute of Health Research (NIHR) is the research arm of the NHS in the UK which specifically commissioned this study having identified that robotic rehabilitation was necessary to further research. The investigating team expects to complete the study in 2018 and publish the results in 2019.
Newcastle University Professor of Stroke Care, Helen Rodgers, Principal Investigator of the study stated, “This landmark study is very important as it gives us the opportunity to evaluate the clinical and cost effectiveness of robotic rehabilitation in a clinical setting with a typical patient group. Importantly, the results of this study will inform the provision of robotic-assisted rehabilitation in clinical practice. It is critical that new health technologies are rigorously and independently evaluated as this will enable us to determine the effectiveness of robotic-assisted rehabilitation which has the potential to revolutionize rehabilitation treatment programs for stroke patients.”
RATULS is a multicenter, randomized controlled trial to determine the clinical effectiveness of robot-assisted training upon upper limb function after stroke and is expected to enroll 720 participants. The stroke patients with reduced arm function who enroll in the study are randomly assigned to one of the three groups: robot-assisted training, enhanced upper limb therapy, or usual NHS rehabilitation. Robot-assisted training will be compared to an enhanced upper limb therapy program consisting of repeated practice of everyday activities using the arm and usual NHS rehabilitation.
The study consists of three therapy sessions per week lasting approximately one hour using the InMotion robotic gym system, involving training of the arm, wrist and hand. Effectiveness of robot-assisted training will be evaluated by comparing the upper limb function of patients in each randomization group at 3 and 6 months. The primary outcome of the study is the evaluation of improvement for upper limb function at 3 months after randomization as measured by the Action Research Arm Test (ARAT). Secondary outcomes of the study include a number of improvements of upper limb function, as measured by evaluations including the Fugl-Meyer Test, Barthel ADL Index and the Stroke Impact Scale, as well as health economics, and qualitative patient and clinician satisfaction.
Hermano Krebs, Ph.D., M.S., Chief Science Officer of Bionik added, “We are thrilled to be a part of this landmark study, the largest of its kind to date. The RATULS research of robot-assisted therapy is important in the clinical development of the Bionik product pipeline as we aim to offer the best rehabilitation therapies for those affected by neurological disorders. For patients who suffer from a stroke, it is reported that 85% of those patients experience some loss in the ability to use the arm and hand. We believe that the InMotion systems offer people an effective opportunity for therapy to address the decrease in function they experience.”
The study is being funded and conducted under the leadership of Newcastle University and is being funded by the NIHR Health Technology Assessment Programme. Enrollment for this study was initiated in April 2014. The investigating team plans to present the results at a scientific congress in 2019 and publish the data from this study in a scientific journal.