Seven hundred and twenty stroke survivors with moderate to severe arm weakness will be randomly assigned to receive robot-assisted training, an enhanced therapy programme, or usual NHS care, in a head-to-head trial running across sixteen stroke services. The problem is that after a stroke, many people are left with a paralysed or poorly functioning arm, and it is unclear whether expensive robotic gym systems offer any real advantage over conventional therapy. Current rehabilitation varies widely, and there is no robust evidence to guide NHS decisions on whether to invest in robotic equipment. If the trial shows that robot-assisted training produces measurably better arm function—defined as meaningful improvements on a standardised 19-task test—then the NHS could begin rolling out these robotic systems to stroke units nationwide. That would change how thousands of patients recover their ability to grasp, grip, and pinch objects each year. If the robots prove no better than enhanced therapy, the NHS will avoid a costly investment and focus resources on refining the best available hands-on treatment. The study also tracks costs to patients and the health service, and interviews with around one hundred participants and staff will reveal what it is actually like to use the technology in practice.
View original technical description
Design: A pragmatic multicentre randomised controlled trial; cost analysis; and process evaluation. Setting: Sixteen NHS stroke services will recruit participants from stroke units, hospital and community rehabilitation services, and primary care registers. Four stroke services where a MIT-Manus robotic gym system is based will act as study 'hubs' and provide all robot assisted training. Three stroke services adjacent to each hub will be study ‘spokes' and provide enhanced therapy and usual care. Target Population: Adults at least one week post stroke with moderate to severe upper limb functional limitation (Action Research Arm Test score 0-39 (0=no function and 57=full arm function) who can comply with the trial protocol will be invited to participate. Patients with both acute and chronic stroke will be recruited to reflect how robot assisted training will be used within the NHS if it is clinically effective and affordable. Health Technologies Being Assessed: A 3 arm efficacy trial will be conducted. Group 1 will receive robot assisted training using the MIT-Manus robotic gym system. Group 2 will receive an enhanced upper limb therapy programme based upon current evidence based practice and national guidelines. The robot assisted training and enhanced upper limb therapy will be provided for up to 45 minutes per day, 3 days per week for 12 weeks, in addition to usual care. Randomisation: Individual participant randomisation stratified by centre, time since stroke and severity of upper limb impairment via an independent randomisation service. Measurement of Outcomes: Outcomes will be measured at 3 and 6 months post randomisation. The primary outcome will be the Action Research Arm Test (ARAT) which consists of 19 functional movement tasks which are divided into 4 domains (grasp, grip, pinch and gross movement). Outcome assessments will undertaken by a research therapist who is blinded to the randomisation group. Sample Size: The study will be powered to detect a 15% difference in ‘successful outcome’ between each of the 3 pairs of treatments (robot assisted training, enhanced upper limb therapy, usual care) at 3 months (power=80% and significance level of 1.67% because of multiple comparisons). Allowing for 10% drop out this will require a sample size of 720 participants (240 participants per arm). Patients with severe initial upper limb impairment are likely to improve less than those with moderate impairment. ‘Successful outcome’ is defined as: baseline ARAT 0-7 must improve by 3 or more points; ARAT 8-13 improve by 4 or more points; ARAT 14-19 improve by 5 or more points; ARAT 20-39 improve by 6 or more points. Measurement of costs: Data collection from the trial will focus on estimating the cost of the interventions, the use of secondary and primary care, and the costs to patients and their families. The perspective of the costing analysis will be the NHS and patient. Secondary care resource use, primary care resource use and patient costs will be obtained from patient completed questionnaires at 6 months post randomisation. Unit costs will be based on nationally available data and study-specific estimates. An economic model will also be developed to assess the longer terms costs. We will extrapolate from the end of the trial follow up period over the remainder of the participant's life to identify the cost implications of differences in disability. The study will also provide information on both costs and outcomes sufficient for a within trial and model based cost-utility analysis. Qualitative study: Alongside the RCT, a process evaluation will be conducted to understand (i) patients' and health service professionals' experiences of robot assisted training; enhanced upper limb therapy and usual care (ii) factors affecting the implementation of the trial within and across study sites. Semi-structured interviews (n= approx. 100-120 during the project) will be conducted across study sites with max
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know