Abstract
BACKGROUND: Robot-assisted rehabilitation is considered beneficial for functional recovery in patients with stroke, but the therapeutic effect remains inconclusive. The present study investigated the therapeutic effects of gait training assisted by a user-initiated powered exoskeletal robot (UIPER) in patients in the early stage after stroke. We also characterized patients' improvement by analyzing chronological changes in clinical measurements together with gait parameters obtained from internal sensors in the exoskeletal robot. METHODS: In this pilot case-controlled study, 17 and 81 patients with stroke onset durations of < 3 months were included in the robot-assisted combined with conventional treatment (RT + CT) group and conventional treatment only (CT) group, respectively. The UIPER, which provides knee flexion and extension support and has hip and knee sensors, was applied to guide gait performance in the RT + CT group. The patients in the RT + CT group received robot-assisted gait training for 40 min/ session, 1 session a day, and 2-3 sessions a week (6 sessions in total). The primary outcome was the proportion of patients reaching the minimum clinically important difference (MCID) in the 5-meter walking speed (5MWS) assessment, and the secondary outcomes were the MCID for the six-minute walking test, the Berg Balance Scale, the Barthel Index, the Fugl-Meyer assessment, and the timed up and go test before, during, and after the interventions. Gait parameters of the hip and knee were evaluated at baseline, midterm, and final sessions. RESULTS: Gait function improved in both groups after the intervention (both P < 0.05). The primary outcome showed that a greater proportion of patients reached the MCID for the 5MWS in the RT + CT group than in the CT group (70.6 vs. 43.2%, P = 0.040; [Formula: see text] = 0.208). Similarly, in terms of the secondary outcomes, more patients in the RT + CT group reached the MCID for the Barthel index as compared with the CT group (41.2 vs. 17.3%, P = 0.047, [Formula: see text] = 0.220). Gait analysis revealed improvements in gait in the RT + CT group, as indicated by increases in the perimeter and area of the hip-knee cyclogram, as well as the range of motion in the hip joint. CONCLUSIONS: Gait training assisted by UIPER facilitates the recovery of walking speed and activities of daily living in patients with stroke, and these improvements may be related to improvements in gait parameters. Randomized controlled studies with larger sample sizes are needed to confirm these findings. TRIAL REGISTRATION: This trial was approved by the Institutional Review Board of Chang Gung Medical Foundation (No. 202200822B0).