Safety and Efficacy of Early Rehabilitation With Assistance From a Single-Joint Hybrid Assistive Limb in Patients With Total Knee Arthroplasty: A Randomized Controlled Clinical Pilot Study

Background This study aimed to evaluate the safety and effectiveness of knee exercise within four hours after total knee arthroplasty (TKA) using a single-joint hybrid assistive limb (HAL-SJ). Materials and methods This pilot single-blind randomized controlled trial included participants who underwent TKA for osteoarthritis and were randomly allocated to the early rehabilitation (n = 14) or control rehabilitation (n = 16) group. Knee rehabilitation exercises using the HAL-SJ began within four hours postoperatively in the early group and seven days after surgery in the control group. Knee circumference, range of motion (ROM), pain, muscle strength, and extension lag were assessed before and one and two weeks after surgery. Results Circumferences at 1 and 10 cm from the upper edge of the patella did not differ between the groups before surgery or one week postoperatively. The extension lag and knee flexion ROM after one week were significantly better in the early intervention group than in the control group. However, the quadriceps and hamstring isometric knee strength and pain scores did not differ between the groups at one and two weeks postoperatively. HAL-SJ-related complications were not reported. Conclusion Rehabilitation knee exercises using the HAL-SJ within four hours after TKA improved extension lag and knee flexion ROM without exacerbating knee swelling and pain.