FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity

Effects of Extracorporeal Shock Wave for Upper Limb Flexor Spasticity in Stroke Patients: A Randomized Controlled Trial

Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.

This study aimed to evaluate the effects of focused Extracorporeal Shock Wave Therapy (ESWT) on upper limb flexor spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific forearm flexor muscles, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.

The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, hand grip strength, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, ultrasound strain elastography, and electromyography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on upper limb function and spasticity in stroke survivors.

Inclusion Criteria:

• Individuals aged 18 years or older with unilateral cerebral stroke.
• Wrist and finger flexor muscle tone with a score greater than 1 on the Modified Ashworth Scale.
• Stable medical condition and vital signs.
• Conscious and able to comply with instructions.

Exclusion Criteria:

• History of more than one stroke, traumatic brain injury, or cerebral neoplasm.
• Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal diseases affecting muscle tone assessment.
• Contraindications for shockwave intervention, such as malignancies, coagulopathies, local infections, or use of cardiac pacemakers.
• Undergone shockwave therapy or botulinum toxin injections for post-stroke spasticity in the past three months.
• Cognitive, consciousness, or language impairments preventing participation in the intervention or functional assessments.