Pilot clinical study about the effects of a dynamic pseudoelastic orthosis equipped with sensors for the treatment and evaluation of chronic stroke patients.

Introduction: We designed and built customised orthotic devices able to provide a non-linear corrective force for the repositioning of the elbow joint. The purpose of this study is to evaluate if those orthoses with pseudoelastic characteristics can improve posture and increase functional movement abilities in stroke patients. On-board sensors were used to investigate the dynamic interaction of patients and orthoses during standardised motor tasks. Methods: Six chronic hemiplegic patients (age 56.16±7.22 years) were enrolled for the study and were prescribed to wear a custom-made orthosis for at least 6 hours a day for a month. Patients were evaluated before and after this period using several scales, including Fugl-Meyer (F-M), Modified Ashworth Score (MAS), and WOLF Motor Function Test (WMFT). Furthermore an accelerometer and an analogic potentiometer on-board the orthosis were used to evaluate quantitatively the performances of patients during the execution of motor tasks such as Reaching Foreward, Hand to Mouth and Timed Upand- Go. Results: The present orthotic treatment produced mild improvements in several articular and functional parameters. For instance MAS (Elbow) decreased by 1±0.89 (p=0.02), F-M (items A-D) improved by 1.66±1.13 (p=0.01) and WMFT increased by 4±4.35 (p=0.05). Improvement in movement speed in the hand-to-mouth task (from onboard sensor) seems to be greater for patients with high pre-treatment MAS (Pearson R2=0.82). Reaching Foreward times decrease by 19.1±20.5% (p=0.035). Spectral analysis of measured accelerations can separate movement uncertainties from cloni. Conclusions: This pilot study showed that a pseudoelastic orthotic treatment can promote moderate reacquisition of segmental mobility of the upper limb in chronic hemiplegic patients. The parameters collected by on-board unit are a promising tool for identifying patterns of movement in evaluation tasks and monitoring variations during the therapy; this resource could be used in future for implementing home-based tele-rehabilitation.