Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity

This pilot randomized controlled trial (RCT) aims to assess the clinical effectiveness and efficacy of adding focal muscle vibration (FMV) to anti-spastic splint therapy for individuals with spasticity following a stroke. The study involves multiple centers in the Jenin area of Palestine, utilizing outpatient rehabilitation centers to recruit participants who have chronic spasticity post-stroke. Study Objectives and Questions: Determine whether adding FMV to anti-spastic splint therapy provides additional benefit for individuals with spasticity after a stroke. Compare the outcomes of anti-spastic splint therapy, FMV therapy, and a combination of both interventions in individuals with post-stroke spasticity. Explore participant perceptions regarding the effectiveness, acceptability, and adherence to the interventions. Study Design and Procedures: The study is a pilot, multi-center RCT with a single evaluator (evaluator-blind) approach to avoid bias. Forty-eight participants will be randomly assigned to one of three groups: Arm 1 (anti-spastic splint and FMV), Arm 2 (FMV only), or Arm 3 (anti-spastic splint only). Interventions will be delivered by trained rehabilitation specialists, including occupational and physical therapists. Standardized intervention protocols will guide the delivery of FMV and anti-spastic splint therapy for a period of four weeks. Participant Recruitment: Participants with chronic post-stroke spasticity are recruited from multiple rehabilitation centers and screened based on specific inclusion and exclusion criteria. Convenience sampling is used to enroll participants from available populations in the participating centers. Data Collection and Management: Baseline and post-treatment evaluations include measurements of spasticity, hand functionality, range of motion, and pain level. Qualitative interviews will explore participants' experiences with the interventions and their perceptions of the treatments' effectiveness. Data will be securely stored and anonymized to protect participants' privacy. Statistical Analysis Plan: Linear Mixed-Effects Models (LMEM) will be used to assess treatment effects, adjusting for correlation over time within participants. The safety analysis will involve documenting and summarizing adverse events (AEs) across treatment groups. The study aims to provide preliminary data on treatment effects and inform the design of future larger RCTs.