A landmark Robot Assisted Training for the Upper Limb after Stroke (RATULS) trial utilizing BIONIK Laboratories Corp’s InMotion Robotic Therapy Systems was completed recently, the Toronto-based company announces.
The RATULS trial, which began in 2014 and was completed at the end of 2018, compared the clinical effectiveness of robot-assisted training, enhanced upper limb therapy, and usual care for patients with moderate or severe upper limb functional limitation.
Results were presented recently at the European Stroke Organisation Conference (ESOC) in Milan, Italy, and published in The Lancet.
“We are pleased that the RATULS trial confirmed the finding of previous research studies which demonstrated that robot-assisted therapy improved upper limb impairment when compared with conventional care methods for stroke victims.
“The trial’s finding that robotic therapy is the only therapy to statistically maintain a significant impairment advantage at six months after treatment is a strong signal that robotic therapy is critical for achieving positive patient outcomes,” says Dr Eric Dusseux, CEO, BIONIK Laboratories, in a media release.
For the RATULS trial, the primary outcome for upper limb success was determined by Action Research Arm Test (ARAT), with four distinct success criteria that varied according to baseline severity, not used previously and developed by the RATULS trial team.
Although the findings demonstrated that robot-assisted therapy improved upper limb impairment, using this ARAT measurement, the trial was unable to conclude that robot-assisted therapy or enhanced upper limb therapy resulted in improved upper limb functionality after stroke compared with usual care provided to patients with stroke-related upper limb functional limitation. The attrition rate was also drastically reduced in patient population following either robotic therapy or enhanced upper limb therapy versus usual care only, and most of the withdrawals before 3 months in usual care were due to disappointment with treatment allocation, the release explains.
“The combination of evidenced-based medicine and real-world clinical feedback have led to the release of substantially improved versions of the InMotion ARM Robotic Therapy System announced in early 2018, and the InMotion ARM/HAND Robotic Therapy System announced beginning of 2019. These versions of our products include enhanced software applications with patient-centric configurable protocols to assist the therapist in providing specialized treatment of stroke and traumatic brain injury.”
[Source(s): BIONIK Laboratories Corp, Business Wire]