Abstract
Introduction: Impaired coordination within the shoulder complex is a frequent symptom in post-stroke survivors. However, most devices that have undergone clinical trials are unable to actively assist the full movement of the shoulder girdle. Purpose: In this study, we aim to evaluate the safety of the Harmony robot in post-stroke rehabilitation and to understand the needs of the user and the clinicians. Methods: The Harmony exoskeleton is a bilateral device with seven degrees-of-freedom in each arm, which has an anatomical shoulder mechanism that can provide active assistance for the shoulder girdle. Each subject underwent seven one-hour training sessions in which six arm trajectories based on functional therapeutic exercises were trained with robotic assistance. Position and torque data during movements were captured by the robot’s sensors. Heart rate, blood pressure, and subject pain and safety perception of the robot were measured in each session. Results: Three (3) subjects have completed the study. The mean donning and doffing times were 3’56” and 1’21”, respectively. The mean improvement in Fugl-Meyer UE and Action Research Arm Test scores was 6 and 4.3 points, respectively. The stability of the glenohumeral joint during multi-joint 3D movements was maintained as evaluated by an occupational therapist. All subjects reported their safety perception to be maximal (very safe); no adverse events have been reported. The mean anxiety score of the subjects was 1.4 on a scale from 1 (no anxiety) through 10 (extreme anxiety). The mean heart rate change during a session was 4.1 bpm, suggesting subjects were not showing signs of exhaustion or stress; average variation in heart rate across sessions was 11 bpm. No moderate or severe pain was reported along the experiments. Conclusions: These results suggest that the Harmony exoskeleton can safely assist in the completion of complex upper-limb movements with reasonably short donning-and-doffing times. Our results also suggest that robotic-assisted therapy has great potential to motivate and engage patients in their treatment.
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