Prof Helen Rodgers is the Chief Investigator for the Robot Assisted Training for Upper Limb after Stroke (RATULS) clinical trial. RATULS is the largest robot upper limb trial in the world and one of RATULS’ four centres is in our region. We recently caught up with Helen to talk about how her team discovered the robot, the use of medical devices in clinical trials and how the trial could impact the NHS.
RATULS is a NIHR Health Technology Assessment (HTA) funded study evaluating the clinical effectiveness and cost effectiveness of robot assisted upper limb rehabilitation for stroke survivors. The trial has two intervention treatments: a robot assisted training programme and an enhanced upper limb therapy programme. Control group patients receive usual NHS care. Participants randomised to receive the robot assisted training programme or the upper limb therapy programme receive a one hour treatment session, three times a week for 12 weeks. We plan to recruit 720 participants in RATULS and it is going to be the biggest trial of robot assisted rehabilitation.
If it’s a positive trial, we would show that robot assisted rehabilitation improves upper limb function following a stroke and that it is a cost effective treatment. We would then need to undertake a meta-analysis to understand how our results fit into the existing evidence base for robot assisted rehabilitation. We would then seek to implement robot assisted training throughout the NHS and to make it widely available for patients with moderate or severe upper limb impairment due to stroke.
Robot assisted rehabilitation will not to replace physiotherapists. Therapists will still use their expertise to assess patients and to decide whether this particular treatment is appropriate and design a programme according. Robot assisted training is for people who have moderate to severe loss of upper limb function so these are people who really can’t move their arm or have no or very little functional movement in their arm. Based on the evidence, repetition is really important for upper limb recovery. The robot enables repetitions to be completed via a video game but the feedback, encouragement and support is provided by a therapist. There is also scope for rehabilitation teams to have robot gyms, similar to those in the United States where therapists can supervise more than one patient at a time, but some patients will still need one to one care. Robot assisted rehabilitation is a new technology which therapists can use within a wider rehabilitation programme.
The call came out for studies of robot assisted rehabilitation for upper limb recovery after stroke. Although we have undertaken trials of upper limb rehabilitation we didn’t know anything about robots so we weren’t sure if this was something we would pursue. I looked online and found two robots that caught my eye in the States and sent two emails to the people responsible for them. I then got a call from Igo Krebs, a Bioengineer from MIT, Boston who had developed the MIT Manus which is a robot for upper limb rehabilitation. We had a few teleconferences and I went out to see him and MIT Manus. We hadn’t quite worked out how we would get the robots until just before outline bid was submitted. We were collaborating with the only three Trusts who had a MIT Manus in the UK, but none of the Trusts in the North East had a robot. I wrote an email to the CEO of Northumbria Healthcare NHS Foundation Trust where I am an honorary consultant stroke physician and said I’d really like to have a centre in the North East, this would be really exciting and wouldn’t it be a great thing to do? I got a ‘we’ll see what we can do’ reply. I was delighted that he agreed to support the study and we have the most up to date robot in the UK.
I will never say recruitment is successful until we’ve randomised the last participant! We have 425 participants so far and we’re hoping to recruit 720 participants from four centres across the UK (North Tyneside, Glasgow, Romford and Northwick Park). Although MIT-Manus, which is the robotic device we are evaluating, is based at North Tyneside General Hospital we receive referrals from Newcastle, Gateshead, South Tyneside, Bishop Auckland, Wansbeck and Hexham. This is very much a collaborative study across the North East. We are marginally behind recruitment and may need to apply for an extension.
For me, it’s important to make sure that we’ve got a realistic plan from the beginning, as well as the correct infrastructure in the coordinating centre and at sites to ensure the trial starts on time and delivers the study as per protocol. It’s important to work closely with local sites to plan the study, train local teams and to have regular communication and feedback.
MIT Manus already had a CE mark, so there were a number of hurdles that we did not need to cross. Setting up the study was a bit of a challenge as the robot isn’t classed as a research cost but as an Excess Treatment Cost (ETC) and unfortunately you can’t buy equipment which is classed as an ETC from NIHR as it funds research costs. Three of the centres had an older version of MIT Manus which they had used in previous research studies. We obtained support from a NHS subvention, local Trusts, and commissioners to fund a new robot at NTGH and for upgrades at the other centres.
One of the big challenges we’ve faced is to ensure that people understand they are taking part in a research study rather than being offered a new treatment. When giving consent to participate in the study it is important that participants are aware and accept that they may be randomised to receive usual care.
We’ve had patients actively involved throughout the study, we have a patient on our steering group, we have patients on our study management group, we’ve been to the research groups nationally and locally to discuss the study design and progress and we will ensure that all study participants receive the results of the study.
For rehabilitation and probably other medical settings, a device is part of a complex intervention and there is a clear recommended pathway for developing and evaluating complex interventions described and recently updated by the MRC. It’s important to have early discussions to look at the potential clinical value of a device, how it is best evaluated in a clinical setting, and how it can be implemented in the NHS.
I think it’s very easy to underestimate the amount of time and planning that a big study needs. In our HTA funded studies we have ensure that we have sufficient time between receipt of funding and the start date to make sure we have the infrastructure, training and everything in place before the study begins.