Trial reportCritical care (London, England)2026
Efficacy of suspension-based lower-limb rehabilitation device in enhancing lower limb function among patients with ICU-acquired weakness: a self-controlled randomized clinical trial.
Trial report in Critical care (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundIntensive Care Unit-acquired weakness (ICUAW) is a common and debilitating complication in critically ill patients, resulting in substantial functional impairment and reduced quality of life. Although early mobilization is widely recommended, the most effective rehabilitation strategy remains unclear. This study aimed to evaluate the short-term clinical efficacy of a suspension-based lower-limb rehabilitation device (SS) combined with conventional rehabilitation in prompt improvement of lower-limb function in patients with ICUAW after diagnosis.
methodA prospective, within-patient randomized controlled trial with a two-year study period. Sixty patients with ICUAW were enrolled, with one lower limb designated as the intervention side, receiving SS-assisted training plus standard physical therapy, and the opposite limb serving as the control, receiving standard physical therapy alone. Both limbs received 40 min of therapy daily, 5 days per week, for 2 consecutive weeks. Assessments were conducted at baseline (study enrolment), 1 week, and 2 weeks. The primary outcome was the change in lower-limb muscle thickness involving the rectus femoris, vastus intermedius, vastus medialis, vastus lateralis, and tibialis anterior, assessed by musculoskeletal ultrasound. Secondary outcomes included the Medical Research Council (MRC) score, active range of motion (AROM), and limb circumference.
resultsMixed-effects model analysis of muscle thickness showed a significant interaction between group and time (p < 0.001) and a significant main effect of group (p = 0.001). Post-hoc analysis revealed that at two weeks, muscle thickness in the control limb was significantly lower than in the intervention limb (p < 0.01). In the control limb, muscle thickness was significantly reduced at both 1 week and 2 weeks compared with baseline (p < 0.01), with no significant difference between the two time points (p = 0.06). Notably, no significant within-group changes over time were observed in the intervention limb. Similarly, the control limb showed significantly lower MRC scores than the intervention limb at 1 week (p = 0.05) and 2 weeks (p = 0.003). AROM was also lower in the control limb at 1 week (p = 0.003) and 2 weeks (p < 0.001). No significant interaction or main effect was observed for lower-limb circumference (p = 0.18).
conclusionPrompt intervention with SS-assisted rehabilitation combined with conventional therapy may help attenuate muscle atrophy, improve muscle strength, and enhance hip and knee AROM in patients with ICUAW, potentially offering a novel rehabilitation strategy for this population.
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