Phase-II Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity

摘要: Background: Spasticity is a typical motor disorder in patients affected by stroke. Typically post-stroke rehabilitation consists of repetition mobilization exercises on impaired limbs, aimed to reduce muscle hypertonia and mitigate spastic reflexes. It currently strongly debated if the treatment’s effectiveness improves with timeliness its adoption; particular, starting intensive as close possible stroke event may counteract growth postpone onset spasticity. In this paper we present phase-II clinical validation robotic exoskeleton treating subacute patients. Methods: Seventeen participated 10 daily sessions using NEUROExos Elbow Module exoskeleton, each one lasting 45 minutes: consisted isokinetic passive elbow, torque threshold detect excessive user’s resistance movement. We investigated safety reporting adverse events, such mechanical, electrical or software failures device injuries pain experienced patient. As regards efficacy, Modified Ashworth Scale, was identified primary outcome measure NEEM metrics describing elbow joint extension (i.e. maximum zero-torque angle) secondary outcomes. Results: During entire duration treatments no events for were reported. No statistically significant differences found Scale scores, between pre-treatment post-treatment follow-up sessions, indicating absence spasticity increase throughout (14 days) after (3-4 months follow-up) treatment. Exoskeleton confirmed difference pre- data, whereas intra-session data highlighted outcomes, toward decrease subject’s resistance. Conclusions: The results show that our can be safely used prolonged suggest early treatment prevent occurrence at later stage. Moreover, reliable compared sensitive revealing changes extension, agreement evidences.