Early efficacy observation of suspended lower-limb rehabilitation robot-assisted therapy in patients with intensive care unit-acquired weakness: a study protocol for a self-controlled randomised controlled trial.

Abstract

Intensive care unit-acquired weakness (ICUAW) is a common and severe complication in critically ill patients, associated with high morbidity and poor prognosis. Despite increasing focus on ICUAW, definitive diagnostic and therapeutic strategies remain absent. Early mobilisation has been demonstrated as an effective intervention for preventing and alleviating ICUAW. This study aims to evaluate the early-stage efficacy of suspended lower-limb rehabilitation robot-assisted therapy in patients with ICUAW. This study is a self-controlled randomised trial aiming to include 60 patients with ICUAW. Each patient's lower limbs will be randomly assigned to either the experimental group or the control group. The control group will receive standard rehabilitation therapy, while the experimental group will receive additional suspended lower-limb rehabilitation robot-assisted therapy alongside standard care. The intervention will be delivered for 40 min daily, 5 days per week, over a 2-week period. The primary outcome measure is the thickness of key lower-limb muscles assessed via musculoskeletal ultrasound. Secondary outcome measures include the Medical Research Council score, range of motion of the lower-limb joints, and limb circumference. Data will be collected at baseline, after 1 week of intervention and at the 2-week endpoint. This study has received ethical approval from the Research Ethics Committee of Changhai Hospital, affiliated with the Naval Medical University (approval reference: CHEC2023-055). Written informed consent will be obtained from all participants prior to their inclusion in the study. The findings, including both positive and negative outcomes, will be disseminated through publication in international peer-reviewed journals and presentation at relevant academic conferences. ChiCTR2300070118.