Telerehabilitation robotics for upper limb rehabilitation after stroke (TRUST): a multi-site pragmatic trial protocol

Stroke remains a leading cause of long-term disability globally, with upper limb impairment persisting in 39% of survivors at six months. The post-acute rehabilitation gap, characterized by precipitous decline in therapy intensity after hospital discharge, compromises recovery during critical neuroplastic windows. While robot-aided therapy (RAT) demonstrates efficacy comparable to conventional therapy, widespread implementation remains limited by cost, complexity, and facility-based care models. Home-based, minimally supervised RAT with telemonitoring could address these barriers while providing intensive therapy without proportional increases in healthcare resources.

To evaluate the feasibility, acceptability, clinical effectiveness, and cost-effectiveness of home-based minimally supervised RAT using a portable planar robot in patients with moderate upper limb impairment following stroke.

This pragmatic, single-arm, multi-center prospective trial will recruit 54 adults with subacute to chronic stroke (>28 days post-event) with upper extremity impairment (Fugl-Meyer Assessment 10-60) across three tertiary rehabilitation centers in Singapore. The intervention comprises four weeks of intensive home-based, caregiver-supervised training using the H-Man robot (60-120 min daily) with weekly telemonitoring, combined with four conventional occupational therapy sessions over an eight-week treatment period. The primary outcome is utilization rate (≥75% compliance) measured by cloud-based metrics. Secondary outcomes include motor impairment (FMA-UE), functional capacity (ARAT), quality of life (EQ-5D-5L), usability (System Usability Scale), and technology acceptance, assessed at baseline, 6, 8, 12, and 24 weeks. Economic evaluation will assess cost-effectiveness from healthcare system and societal perspectives.

Recruitment commenced October 2024 across three Singapore rehabilitation hospitals. The study employs rigorous safety monitoring, standardized training protocols, and cloud-based performance tracking. Preliminary feasibility testing demonstrates acceptable device usability and caregiver support requirements.

TRUST addresses critical gaps in post-stroke rehabilitation by evaluating a scalable model combining technology-enabled home therapy with remote clinical oversight. Results will inform implementation strategies for integrating home-RAT into standard care pathways, potentially transforming stroke rehabilitation delivery in resource-constrained healthcare systems facing growing demand from aging populations.

ClinicalTrials.gov, identifier NCT06270459.