This study aims to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in individuals with lower limb spasticity following stroke. Spasticity is a common complication after stroke and can negatively affect walking ability, mobility, and quality of life.

Participants will be randomly assigned to one of two groups. Both groups will receive a standard physiotherapy and rehabilitation program. In addition, the intervention group will receive ESWT applied to the lower limb muscles, while the control group will receive a sham (placebo) ESWT application.

The treatment program will be conducted three times per week for four weeks. Clinical assessments will be performed at baseline, after treatment, and during follow-up.

The main outcomes of the study include muscle tone (spasticity), walking performance, motor function, and quality of life. The results of this study may help improve rehabilitation strategies and provide evidence for the use of ESWT in stroke patients.

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.

Inclusion Criteria:

• Adults aged 18-65 years
• Diagnosed with ischemic or hemorrhagic stroke at least 3 months prior to enrollment Presence of lower extremity spasticity with a Modified Ashworth Scale (MAS) score ≥1+
• Ability to walk independently with or without assistive devices
• Ability to understand and follow instructions for exercise interventions and assessments
• Provided written informed consent

Exclusion Criteria:

• Receipt of botulinum toxin injection in the affected lower limb within the last 3 months
• Severe cognitive impairment preventing participation in assessments
• Presence of fixed joint contractures limiting range of motion
• Orthopedic or musculoskeletal disorders affecting lower limb function (e.g., fracture, severe osteoarthritis)
• Uncontrolled cardiovascular, respiratory, or systemic disease contraindicating exercise
• Participation in another interventional clinical trial
• Any condition judged by the investigator to interfere with participation or safety

IPD Sharing Description:

De-identified individual participant data (IPD) collected during this study, including demographic information, clinical assessments, and outcome measures (Modified Ashworth Scale, Fugl-Meyer Assessment, Timed Up and Go, 10-Meter Walk Test, 6-Minute Walk Test, and Stroke-Specific Quality of Life scores), will be made available to qualified researchers for secondary analyses. Data sharing will be subject to a signed data use agreement to ensure confidentiality and compliance with ethical standards. Data will be accessible after publication of the primary study results or upon reasonable request, and will include a data dictionary and study protocol to facilitate proper interpretation.

IPD and supporting information will be available starting 3 months after publication of the primary study results and will remain accessible for 5 years.

Qualified researchers affiliated with recognized academic or clinical institutions may request access to de-identified participant data and supporting documents. Requests must include a research proposal and signed Data Use Agreement to ensure confidentiality and adherence to ethical standards. Access will be provided via secure data transfer or a controlled-access repository managed by the study coordinating center.

This study is designed as a single-blind trial. Participants will be blinded to group allocation through the use of sham ESWT in the control group. Outcome assessors will also be blinded to the intervention groups. The therapist delivering the treatment will not be blinded.