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Case study: Study Support Service - Developing a digital solution to help patients to regain their mobility

The NIHR supports medical technology, device and diagnostic companies in the innovation and translation of new medical technologies and diagnostics.

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Digital solution has patients playing their way to recovery

NHS patients in Manchester have had their physical rehabilitation programmes transformed by the introduction of MIRA; a digital approach to physiotherapy that turns exercises into video games, making the therapy fun and easy to follow.

“Amy is funded by the NIHR and I have to say she is the main engine of the study. We need to recruit a minimum 72 patients to achieve statistical relevance. With Amy’s help we’ve recruited 67 patients so far and the study is open until March 2019 so we are pleased with our progress."

Entrepreneur Cosmin Mihaiu is the CEO and Co-founder of MIRA Rehab Ltd, a London-based SME (Small-to-Medium Enterprise), which was established to help patients to regain their mobility by using clinically guided ‘exergames’. He’s keen to convey the benefits of MIRA:

 “MIRA is a medical device that uses motion tracking sensors to gamify physical therapy and increase patient compliance, enabling them to play their way to recovery. The system is being used in over 72 institutions worldwide, helping over 600 patients each month for a variety of neurological or musculoskeletal conditions. The patients’ ages range from three to 102 years old. The software can be programmed in different ways, it’s a tool that physiotherapists can tailor depending on the needs of their patients.” Although a variety of trials of the product are currently taking place from Malaysia to Manchester, Cosmin understands that, in the UK, robust clinical evidence is the only route to wider adoption of the technology. He continues:

“Many private health organisations are interested in MIRA and some are trialling the technology in ‘try before you buy’ arrangements. But if we want MIRA to be widely available on the NHS, then we need to generate relevant and reliable clinical evidence here in the UK.

“The GAME study, which is taking place in Manchester, is one of several studies around the world investigating the potential of MIRA. The gaming approach has very wide appeal among patients and there are clear benefits for the NHS too, which we hope GAME will help demonstrate.”

Mr Bibhas Roy is a consultant orthopaedic surgeon at Trafford General Hospital, Manchester, and Chief Investigator of the GAME study. He agrees that there could be many advantages of introducing a product like MIRA to physiotherapy services:

“The main benefit is that it will complement standard physio. The patient can do their exercises at home with the game acting as the guide to make sure that exercises are done correctly. This will create real potential to replace up to one third of live physiotherapy sessions. For example, a patient requiring 15 face-to-face sessions may only need 10 if they use MIRA."

“In addition, when using MIRA, one physiotherapist will be able to treat two people at the same time by working between two gaming stations in the clinic. This cuts live physio sessions again by half, which means that more patients can be treated with the same resource. It will mean reduced costs to the system and reduced trips to the clinic for patients."

“Another key benefit is better patient engagement. The gamification principle allows you to set targets and track and compare scores. This incentivises patients to comply with their therapy programmes, but most of all, it’s fun.”

Translating this idea into the clinical setting as a research study required careful consideration to ensure the evidence generated met the required standards for future NHS adoption. Bibhas Roy prides himself in being ‘involved in innovation’ and was keen to help Cosmin bring his product to the NHS. His clinical expertise is a crucial ingredient of the GAME study:

“When Cosmin got in touch to tell me about his product and ask advice about conducting research in the NHS looking at rehabilitation after shoulder surgery, I was keen to explore the options. However, the initial step was to ensure that the evidence we generated was relevant and robust for the NHS."

“Firstly we needed to be absolutely clear about what we were measuring - a process called validation. Secondly we needed to spend time getting the device settings correct to ensure it measures what we want to measure - this is called calibration. Both these processes were lab-based and had to be completed before we moved on to clinical validation by using the device with patients.”

The GAME study is an Investigator Initiated Study (IIT) which is classed as a non-commercial study on the NIHR Clinical Research Network Portfolio. It received NIHR support to set-up four sites and also in the form of Clinical Research Nurse, Amy Barratt, to help deliver the study. Bibhas Roy believes this support from the NIHR was invaluable and speaks highly of Amy’s involvement:

“Amy is funded by the NIHR and I have to say she is the main engine of the study. We need to recruit a minimum 72 patients to achieve statistical relevance. With Amy’s help we’ve recruited 67 patients so far and the study is open until March 2019 so we are pleased with our progress."

“The recruitment process is challenging because, although pre-consent is achieved in patient consultations, actual patient consent has to be acquired on the day of surgery. This means that Amy has to be present whenever I am operating. She is absolutely crucial in gaining that consent. Then, once the consent is acquired, Amy has to complete a system of measurements of movement with each individual patient to establish a baseline before their surgery. Amy is flexible and supportive, she fits in well as an integrated member of the clinical team."

Although the findings of the study are not ready yet, Bibhas is optimistic about the prospective results:

“The aim of the GAME study is simply to show that MIRA is ‘just as effective’ as standard physiotherapy following arthroscopic subacromial decompression procedure - an operation on your shoulder which is used to treat a condition called shoulder impingement. This is when the bones and tendons in your shoulder rub against each other when you raise your arm, causing pain."

“If we can prove that is the case, and we hope that we can, then the resulting time and resource savings will enable us to extend our physiotherapy services to more patients. And there could be real advantages to be gained from introducing MIRA more widely. We are already have plans for a further study in the pipeline looking at the prevention of falls in the elderly.”

The potential of MIRA has certainly sparked a lot of interest. Cosmin describes how the device is already being used in pockets in the NHS for paediatric rehabilitation. He also reveals that a new study protocol, investigating if MIRA can help children with long-term conditions, funded by the NIHR i4i fund, as soon as it receives ethics approval. He is confident that overtime we will see MIRA being used for a broad range of indications in the NHS:

“The more NHS trials that take place, the more we will be able to demonstrate the potential of the product. Generating that evidence is a necessary part of being able to extend MIRA to more patients.”

Read a related blog from Cosmin Mihaiu explaining how clinical collaboration helped translate his state-of-the-art video game technology to improve patient physiotherapy outcomes.

“The recruitment process is challenging because, although pre-consent is achieved in patient consultations, actual patient consent has to be acquired on the day of surgery. This means that Amy has to be present whenever I am operating. She is absolutely crucial in gaining that consent. Then, once the consent is acquired, Amy has to complete a system of measurements of movement with each individual patient to establish a baseline before their surgery. Amy is flexible and supportive, she fits in well as an integrated member of the clinical team."