Effects of blood flow restriction combined with robot-assisted training on upper limb motor function after stroke: a randomized controlled trial protocol

Abstract

Background – Upper limb motor dysfunction is common after stroke and substantially restricts independence. Robot-assisted training (RAT) and blood flow restriction training (BFRT) have individually demonstrated potential benefits, but evidence regarding their combined application for upper limb rehabilitation after stroke remains limited. Objective – This study aims to investigate the effectiveness of RAT combined with BFRT in improving upper limb motor function among stroke survivors. Methods and analysis – This assessor-blinded randomized controlled trial will enroll 100 participants. Participants will be randomly assigned to one of four groups: (A) upper limb RAT combined with BFRT (UL-RAT + BFRT), (B) UL-RAT combined with sham BFRT, (C) BFRT combined with conventional occupational therapy, or (D) conventional occupational therapy alone. All interventions will be delivered once daily, 5 days per week, for 4 weeks. The outcome measures will include upper limb motor function assessed by the Fugl–Meyer Assessment, Upper limb and muscle strength, surface electromyography, Motricity Index–Upper Limb, grip strength, Action Research Arm Test, and Modified Barthel Index. Outcomes will be assessed at baseline and immediately after the intervention. Data will be analyzed according to the intention-to-treat principle, with statistical significance set at 0.05 (two-sided). Conclusion – This trial will evaluate the feasibility and potential effectiveness of combining BFRT with RAT for post-stroke upper limb rehabilitation. Clinical trial registration – https://www.chictr.org.cn/, identifier ChiCTR2500096611.