Study of Extra-corporeal Shock Wave Therapy Combined With Botulinum Toxin Type A for Upper Limb Spasticity from Brain Injury or Stroke

What this Trial Is About

Researchers are evaluating the effectiveness of adding Extra-corporeal Shock Wave Therapy ESWT to Botulinum Neurotoxin Type A BoNTA treatment for people with upper limb spasticity caused by brain injuries such as stroke, traumatic brain injury, or cerebral palsy. Spasticity is a challenging condition that affects movement and quality of life. This pilot study aims to compare clinical and patient-reported outcomes between combined ESWT and BoNTA treatment and BoNTA treatment alone to explore potential improvements in spasticity management. The study involves two groups one receiving standard care with BoNTA injections plus a sham ESWT treatment that mimics the device sounds without delivering shockwaves, and the other receiving BoNTA plus actual ESWT using a specialized device delivering high-intensity shockwaves to the affected upper limb muscles. Treatments will be delivered over several visits at a specialized spasticity clinic. The study is randomized and placebo-controlled, with 20 participants in each group. Participants will attend 10 to 11 study visits for treatment, assessments, and data collection including patient-reported spasticity and pain scales, quality of life questionnaires, and physical measurements of muscle stiffness and joint range of motion at baseline and at 4, 12, and 24 weeks after treatment. Researchers will monitor safety, treatment adherence, and any adverse events throughout the study, aiming to better understand the benefits and feasibility of combining ESWT with BoNTA in managing upper limb spasticity.

Does ESWT With BoNTA Treatment Improve Outcomes When Compared to Standard Management for Upper Limb Spasticity Patient.