Technology-Assisted Rehabilitation Gym for at-home Training (TARGeT) for stroke survivors: A study protocol for evaluating feasibility, safety, usability, clinical benefit, and costs.

Abstract

Stroke is a leading cause of long-term disability, with more than half of survivors experiencing persistent upper limb impairments. Despite clear evidence that high-dose, repetitive, task-specific training is essential for motor recovery, many stroke survivors do not receive a sufficiently high therapy dose - particularly in the outpatient phase. Limited therapist availability, high care costs, and travel burdens remain key barriers to accessing rehabilitation training. While technology-assisted rehabilitation has emerged as a promising solution, most existing studies are limited to single-device interventions, are conducted in clinical settings, and/or require constant supervision, thereby restricting their scalability and impact. This study protocol presents the Technology-Assisted Rehabilitation Gym for at-home Training (TARGeT) trial (ClinicalTrials.gov: NCT06406569), which aims to evaluate the feasibility, safety, usability, clinical benefits, and economic potential of a novel, unsupervised, high-dose home-based therapy program that integrates multiple complementary technologies for upper limb stroke rehabilitation. In this single-centre, pilot feasibility trial, up to 30 subacute and chronic stroke survivors will complete six weeks of daily home-based therapy using three complementary rehabilitation technologies that enable self-administered training without therapist supervision. The training will be remotely monitored by clinicians via an online platform that reports data on the training progress. Assessments will be conducted at five timepoints, measuring clinical outcomes (e.g., FMA, ARAT), quality of life, healthcare utilization, and technologies' perceived usability (SUS, RawTLX). The study will assess whether unsupervised, home-based multi-technology rehabilitation is feasible and safe, provides high usability and satisfying user experience, whether it yields clinical outcomes comparable to conventional therapy based on data from previous studies (own data and literature data), and determines the associated costs relative to conventional therapy. The TARGeT program addresses the critical gap in therapy access and intensity by delivering scalable, high-dose rehabilitation directly into patients' homes. Results will inform future trials and support broader adoption of decentralized, technology-enabled stroke rehabilitation.