Stroke is one of the leading causes of long-term disability worldwide and is frequently associated with motor impairments, including spasticity. Post-stroke spasticity is characterized by increased muscle tone, exaggerated tendon reflexes, and resistance to passive movement, which can significantly impair functional mobility, gait performance, and independence in daily activities. Lower limb spasticity, particularly involving the plantar flexor muscles, plays a critical role in limiting walking ability and increasing the risk of falls.
Conventional treatment approaches for spasticity include physiotherapy interventions, oral medications, and botulinum toxin injections. However, these methods may have limited effectiveness, potential side effects, or high costs. Therefore, there is a need for alternative, non-invasive, and effective treatment options.
Extracorporeal shock wave therapy (ESWT) has recently emerged as a promising non-invasive modality for the management of spasticity. ESWT is thought to reduce muscle tone by altering muscle viscoelastic properties, modulating neuromuscular transmission, and improving local blood circulation. Previous studies have suggested beneficial effects of ESWT on spasticity; however, evidence regarding its impact on functional outcomes such as gait performance and quality of life remains limited and inconsistent.
This study is designed as a prospective, randomized, single-blind, sham-controlled clinical trial conducted at a tertiary rehabilitation center. A total of 85 participants with chronic stroke (≥3 months) and lower extremity spasticity (Modified Ashworth Scale ≥1+) will be recruited. Participants will be randomly assigned to either the ESWT group or the control group using a block randomization method.
The intervention group will receive radial ESWT applied to the gastrocnemius and soleus muscles in addition to a standard physiotherapy program. The ESWT parameters will include an energy flux density of 0.10-0.20 mJ/mm², frequency of 5-8 Hz, and 2000-3000 pulses per muscle, administered three times per week for four weeks. The control group will receive sham ESWT with identical procedures but without therapeutic energy delivery. Both groups will undergo a standardized rehabilitation program consisting of stretching, strengthening, balance training, and gait training.
Outcome measures will be assessed at baseline, post-treatment (4 weeks), and follow-up (8 weeks). The primary outcome is spasticity measured by the Modified Ashworth Scale (MAS). Secondary outcomes include walking performance assessed by the 10-Meter Walk Test (10MWT) and Timed Up and Go (TUG) test, motor function assessed by the Fugl-Meyer Assessment for the lower extremity (FMA-LE), and health-related quality of life assessed by the Stroke-Specific Quality of Life (SS-QOL) scale.
The findings of this study are expected to provide high-quality evidence regarding the clinical effectiveness of ESWT in reducing spasticity and improving functional outcomes in stroke survivors. This may contribute to the development of more effective and evidence-based rehabilitation strategies.
