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-Organisational Sustainability of RADTs from Subacute to Chronic Phase (STROKEFIT4)

Abstract

Background: 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. Methods: This is a protocol of a pragmatic multicentre, multimodal, randomised, controlled, parallel-group (1:1) interventional study with blinded assessors aimed at assessing the effectiveness and sustainability of RADT-mediated rehabilitation compared to traditional rehabilitation. The trial will recruit 596 adult subacute post-stroke patients. Participants will be randomised into either the experimental group (using RADTs and two therapists supervising four to six patients) or the control group (individual traditional rehabilitation). Patients in both groups will undergo a comprehensive rehabilitation treatment, targeting (a) upper limb sensorimotor abilities; (b) lower limb sensorimotor abilities and gait; (c) balance; and (d) cognitive abilities. Patients will undergo 25 sessions, each lasting 45 min, with a frequency of 5 (inpatients) or 3 (outpatients) times a week. The primary endpoint is the non-inferiority of RADTs in the recovery of the activities of daily living (ADL) using the modified Barthel Index. If non-inferiority is established, the study will evaluate the superiority. Secondary endpoints will analyse the improvements in the aforementioned domains, as well as changes in neural plasticity and biochemical aspects. Upper limb dexterity and gait recovery rates during treatment will be monitored. The study will also evaluate ADL and quality of life during a six-month follow-up period. Acceptability and usability of integrated RADTs-based rehabilitation for patients, families, and healthcare providers, along with economic and organisational sustainability for patients, payers, and society, will also be assessed. Conclusions: This study aims to establish stronger evidence on the effectiveness of RADTs in post-stroke patients. Trial registration number: NCT06547827.

Keywords: cost-effectiveness analysis; pragmatic clinical trial; rehabilitation; robotics; stroke.

Figure 1

The STROKEFIT4 trial flow-chart.

Figure 2

The treatment rotation scheme. In the first session, rehabilitation will focus on domain A (upper limb); in the second session, on domain B (lower limb); and so forth, progressing through domains C and D before returning to domain A. It should be noted that domain A is further divided into two subdomains: the proximal segment of the upper limb and the distal segment of the upper limb, which alternate in the rotation cycle, as depicted in the figure.

Figure 3

The figure illustrates the rehabilitation interventions provided to patients in the two groups, for the inpatient and the outpatient settings. Specific sessions for the experimental and control groups are shown in green and orange, respectively, while common interventions for both groups are represented in different shades of blue.