Rex Bionics Clinical Trial Shows Potential For Improved Sleep For Patients With Spinal Cord Injury
11/7/2016 9:55:35 AM
• Quality of Life Analysis presented at ACRM conference in Chicago
• Six out of eight sleep indicators show improvement after a single treatment
• Equivalent results between paraplegic and quadriplegic volunteers
7th November 2016: Rex Bionics Plc (AIM: RXB), the pioneer of the REX Robot technology that enhances the mobility of wheelchair users, is pleased to announce positive results from a final analysis of its RAPPER II clinical trial. RAPPER II is multi-centre, international trial to evaluate the feasibility and safety of the REX and of a set of customised exercises performed in a REX; and the impact on quality of life.
The results were presented by Principal Physiotherapy Investigator, Jon Graham BA, MSc, MSCP at the 93rd annual meeting of the American Congress of Rehabilitation Medicine, Chicago Ill.
The analysis focused on the sleep questionnaire, with responses collected before and after a single treatment with REX. In six out of the eight statements, the responses indicated an improvement in sleep reduction, suggesting a beneficial exercise-induced fatigue. The greatest improvement was seen in relation to the proposition “I felt physically tense at night”, where there was a 90% improvement in the mean score of all respondents. The next greatest improvements were seen in “I had trouble stopping my thoughts at bed-time”; and “Pain woke me up”.
The trial’s 18 tetraplegic patients achieved essentially the same results as the 38 paraplegic patients. This confirms that the benefits of the REX technology are available to people with more severe injuries – including those in the upper to mid cervical range in the spinal column. No clear trends were discernible in the pain and spasticity questionnaires that were also used. These questionnaires will be used again in future trials, where there will be not just a single treatment, as in RAPPER II with its focus on safety and feasibility, but with a full course of REX treatment with a therapeutically meaningful frequency and duration. 94% of the volunteers questioned said they would like to use REX on a weekly basis.
The investigators agreed in August 2016, that in view of the strength and clarity of the data, recruitment to the trial should be closed. The final step for RAPPER II is the publication of the trial results in a peer-reviewed journal, expected in 2017.
The next phase of the REX clinical strategy has two elements - the design of a trial in spinal cord medicine to show that REX has a significant and cost-justifiable medical benefit when used in a prescribed course of treatment; and the establishment of trials in other indications, for example - Multiple Sclerosis and Muscular Dystrophy. A trial was recently initiated in Australia for patients with stroke and traumatic brain injury.
Rex Bionics' mission is to establish Robot-Assisted Physiotherapy – in the clinic and at home - as a Standard of Care for people with neurological injury or illness.
Nick Birch, FRCS (Orth), the Principal Investigator of the trial, commented: "The many patients with neurological injury and illness who experience sleep deprivation as a result of pain, will be very encouraged by these results."
Crispin Simon, Chief Executive of Rex Bionics plc added: "RAPPER II has gone according to plan. We have strong safety and usability results; and trends in the quality of life data that are consistent with the positive feedback that we get from patients.”
A copy of this announcement has been posted on the Company's website at www.rexbionics.com/.
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