The Use of Photobiomodulation in the Treatment of Spasticity After Stroke: a Blinded Clinical Trial.
Methods: This blinded, randomized, controlled clinical trial aims to evaluate the effects of PBM on triceps surae muscle spasticity in adults with stroke. Forty-two participants with spastic hemiparesis post-stroke will be randomized into two groups: active PBM (850 nm, 200 mW, 4 J/point in the gastrocnemius, 12 points, weekly for 8 weeks) or placebo PBM (same protocol, device switched off). Both groups will receive the institute's standard rehabilitation treatment. Outcomes will be assessed using the Modified Ashworth Scale (MAS), ankle range of motion, presence of pain, amount of antispastic medication in use, contraction strength (by manual examination) muscle oxygenation (by transcutaneous near-infrared spectroscopy), functionality, and the occurrence of adverse events before and after the intervention. At the end of recruitment, comparisons between groups and between time points will be performed and statistically analyzed using a two-way repeated means ANOVA test and the Generalized Estimating Equations (GEE) test. We also foresee a pilot interim analysis when recruitment reaches a size of 10 participants per group. This interim analysis will be performed using a two-way/means ANOVA to assess effect size and recalculate sample size, making adjustments to the design if necessary.
• Adults who have sustained a unilateral ischemic or hemorrhagic cortical motor stroke, with the diagnosis documented in the acute phase by computed tomography (CT) or magnetic resonance imaging (MRI);
• Patients currently undergoing multidisciplinary rehabilitation at the Rehabilitation Center where the study will be conducted;
• Patients presenting with a motor pattern of spastic hemiparesis secondary to stroke;
• Patients demonstrating the ability to perform orthostatism (standing posture) or therapeutic or functional gait activity.