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Effects of supplemental robot-assisted knee flexion exercise after total knee arthroplasty: a randomized controlled clinical study
Watabe T, Muramatsu R, Sengoku T, Sakurai G, Yoshida S, Kubota M, Asano Y, Taniguchi Y
Journal of Musculoskeletal & Neuronal Interactions 2025 Jun;25(2):178-185
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVES: This study aimed to investigate the beneficial effects of single-joint hybrid assistive limb (HAL-SJ)-assisted rehabilitation after total knee arthroplasty (TKA), with a focus on the early postoperative period. METHODS: This single-anonymized randomized controlled trial assigned 72 participants who underwent primary TKA for knee osteoarthritis to the HAL-SJ (n = 35) and control groups (n = 37). The passive knee range of motion (ROM; ie, the primary outcome) was evaluated preoperatively and at 1 week, 2 weeks, and 3 months postoperatively. Extension lag and knee pain intensity scores were evaluated preoperatively and at 1 and 2 weeks postoperatively. Quadriceps and hamstring isometric knee strength and walking speed were evaluated preoperatively and at 2 weeks postoperatively. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was evaluated preoperatively and at 3 months postoperatively. RESULTS: Compared with the control group, the HAL-SJ group showed significantly improved knee extension ROM (p = 0.001) and greater KOOS Activities of Daily Living subscale score (p = 0.005) at 3 months postoperatively, with a significantly early improvement in extension lag (p = 0.001) and hamstring strength (p = 0.012) at 2 weeks postoperatively. CONCLUSIONS: HAL-SJ effectively supports postoperative rehabilitation, showing clinical advantages for improving daily activities by 3 months after TKA. CLINICAL TRIAL REGISTRATION: University Hospital Medical Information Network (UMIN000053675).

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