CLINICAL TRIALS

Our commitment to engineering excellence is complemented by a commitment to clinical science and trials are now complete or under way in Spinal Cord Injury – including a substantial Tetraplegia sub-group; Stroke; Traumatic brain Injury; Multiple Sclerosis and Neuromuscular Conditions .

The RAPPER II clinical trial results show high levels of practicality, safety and user enthusiasm.

Spinal Cord Injury

RAPPER II is a 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.  56 recruits took part in the study.

In a presentation given at the American Congress for Rehabilitation Medicine, on November 3rd 2016, the trial investigators concluded:

  • Analysis of the results of the RAPPER II trial has shown that REX is a safe and stable Powered Exercise Equipment, requiring a very limited amount of user training
  • The trial has shown that it is feasible for people with SCI to carry out a functional exercise program in the REX
  • There was no difference between the ability of patients with tetraplegia and paraplegia to achieve the functional goals
  • The User Experience was generally positive especially across the domains of safety, comfort, stability and ease of control
  • A substantial cohort of participants felt an improvement in Quality of Life parameters
  • The results of RAPPER II justify further investigation of this technology both in terms of a dose-response relationship and in people with diverse neurological conditions such as stroke and MS.

Click here for News on RAPPER II

Click here for Summary Presentation: November 3rd 2016, presented by Principal Physiotherapy Investigator, Jon Graham BA, MSc, MSCP at the 93rd annual meeting of the American Congress of Rehabilitation Medicine, Chicago Ill.

Click here for REX Case Report: November 16-18 2016, presented by  Gilly Davy, Senior Neurological Physiotherapist and Clinical Director of Connect Neuro Physiotherapy at The Australian and New Zealand Spinal Cord Society (ANZCoS), Adelaide, Australia

Spinal Cord Injury (Tetraplegia)

The presentation of RAPPER II analysis by Principal Physiotherapy Investigator, Jon Graham BA, MSc, MSCP at the 93rd annual meeting of the American Congress of Rehabilitation Medicine, Chicago Ill, showed that:

  • There was no difference between the ability of patients with tetraplegia and paraplegia to achieve functional goals

Click here for Summary Presentation

Multiple Sclerosis

People with Multiple Sclerosis (MS) have successfully used a REX.  The department of Rehabilitation at the East Kent Hospitals University NHS Foundation Trust has designed a clinical trial for the evaluation of REX in MS.

Watch this space for recruitment details early 2017.

Traumatic Brain Injury

People who have suffered a Traumatic Brain Injury have successfully used a REX.

See Stroke and AIN clinical trial.

Neuromuscular Conditions

A clinical trial for Neuromuscular Conditions is being designed by a leading UK hospital.

Recruitment is expected to start in the second half of 2017.

Stroke

People who have suffered a Stroke have successfully used a REX.

A clinical trial is being conducted by the Australian Institute of Neuro-rehabilitation (AIN), Nelson Bay, New South Wales (NSW), Australia and the University of Newcastle, NSW; and is supported by The Newcastle Permanent Charitable Foundation and Rex Bionics plc.  The trial is open to volunteers from the Hunter Region of NSW, who have had a Stroke or Traumatic Brain Injury more than three months previously and have difficulty standing and walking.  Volunteers will be treated twice a week for twelve weeks and the REX treatment will be supplemented by a home programme of exercises.   There is provision for MRI examination to correlate the functional and neurological response to treatment.

Visit the HELLEN website by visiting this link

Or view the Press release here

Recruitment underway.

A further trial for stroke is being designed in New Zealand and the United States.  Recruitment is expected to start in the second half of 2017.

If you would like to find out more or have further questions please get in touch:

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