Rehabilitation with and without Robot and Allied Digital Technologies (RADTs) in stroke patients: a study protocol for a multicentre Randomised Controlled Trial on the effectiveness, acceptability, usability, and economic-organizational sustainability of RADTs from subacute to chronic phase (STROKEFIT4)

Abstract Introduction Rehabilitation after stroke often employs Robots and Allied Digital Technologies (RADTs). However, evidence of their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes. Here, we describe a protocol for a multicentre randomized controlled pragmatic trial aimed at comprehensively and accurately assessing the effectiveness and sustainability of RADT-mediated rehabilitation, compared to traditional rehabilitation. Methods and analysis This is a pragmatic multicentre, multimodal, randomised, controlled, parallel-group (1:1) interventional study with blinded assessors. The trial will recruit 596 adult post-stroke patients in the subacute phase (less than 6 months post-stroke). Patients will be recruited from thirteen rehabilitation centres participating in a national research initiative, encompassing both outpatient and inpatient clinical settings. Participants will be randomized into either the experimental group, or the control group. The experimental group will receive rehabilitation using RADTs within a new organizational model, where two physical therapists supervise four to six patients; patients will undergo a comprehensive rehabilitation treatment, targeting the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; d) cognitive abilities. In the control group, patients will undergo individual traditional rehabilitation, maintaining a 1:1 patient-to-therapist ratio, targeting the same domains. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with a frequency of 5 times a week, for inpatients; and 3 times a week, for outpatients. The primary endpoint is to demonstrate non-inferiority in the recovery of the activities of daily living as measured by the modified Barthel Index. If non-inferiority is established, the study will then evaluate the superiority of RADTs in the recovery of the activities of daily living. Secondary endpoints include improvements in upper and lower limb function, balance, cognitive function, and, according to the ICF, in the body functions, activities, and participation domains. Additional analyses will cover neurophysiological assessments of neural plasticity, as well as biochemical, and genetic evaluations. Upper limb dexterity and gait recovery rates during treatment will be monitored. The study will also evaluate daily activities and quality of life during a six-month follow-up period post-treatment. Acceptability and usability of integrated RADTs-based rehabilitation for patients, families, and healthcare providers, along with economic and organizational sustainability for patients, payers, and society, will also be assessed. Outcomes will be measured and analysed by blinded assessors. Ethics and dissemination This study was reviewed and approved by National Ethics Committee for clinical trials of Public Research Bodies (EPR) and other National Public Institutions (CEN). The results will be disseminated through scientific articles in peer-reviewed journals and presentations at both national and international conferences. Trial registration number NCT06547827 Strengths and limitations of this study • The effectiveness of robotics and allied technologies will be evaluated using a novel approach involving a multimodal intervention. This approach addresses all impaired functions to holistically enhance activities of daily living, which represent the patient’s most important needs. • In addition to clinical scales, neurophysiological and biochemical data will be considered for a deeper understanding of the mechanisms underlying motor recovery. • Detailed patient profiling will enable the creation of predictive models to identify subjects who may respond better to treatment integrated with robotics and allied technologies. • The economic analysis will allow us to assess the sustainability of a new organizational model based on the use of robotics and allied technologies, where two physiotherapists supervise a group of patients simultaneously. • A study limitation is the use of different technologies across research centres. However, this reflects real-world conditions. To address the inevitable variability, we clearly defined the functional domains for treatment with robotic or technological systems, focusing on the lower limbs, balance, upper limb segments, and cognitive functions. Moreover, to manage other possible sources of variability due to the number of centres involved, a consensus was reached about clear protocols for clinical evaluation and therapy administration to be shared in clinical practice by all the participating centres.