Effect of Extracorporeal Shock Wave Therapy on Spasticity and Mobility in Stroke Patients (ESWT-STROKE)

Efficacy of Extracorporeal Shock Wave Therapy on Spasticity, Mobility, Motor Function, and Health-Related Quality of Life in Stroke Survivors: A Prospective Randomized Sham-Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Post-Stroke Spasticity; Lower Limb Spasticity
• Intervention / Treatment: Device: Extracorporeal Shock Wave Therapy (ESWT); Device: Sham Extracorporeal Shock Wave Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehmet Salih SALİH TAN, Doctoral; Phone Number: +905467266876 Türkiye; Email: mstan@medipol.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESWT Group; Participants in this group will receive extracorporeal shock wave therapy (ESWT) applied to the gastrocnemius and soleus muscles in addition to a standard physiotherapy program including stretching, strengthening, balance, and gait training.	Device: Extracorporeal Shock Wave Therapy (ESWT); Radial extracorporeal shock wave therapy will be applied with an energy flux density of 0.10-0.20 mJ/mm², frequency of 5-8 Hz, and 2000-3000 pulses per muscle. Treatment will be administered three times per week for four weeks.
Sham Comparator: Control Group (Sham ESWT); Participants in this group will receive sham ESWT with no therapeutic energy delivery in addition to the same standard physiotherapy program.	Device: Sham Extracorporeal Shock Wave Therapy; A sham ESWT procedure will be performed using the same device without energy transmission, mimicking the sound and sensation of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)	Spasticity will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale ranging from 0 (no increase in muscle tone) to 4 (rigidity). The assessment will be performed on the ankle plantar flexor muscles. A decrease in MAS score indicates improvement in spasticity. Spasticity will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale ranging from 0 to 4, where: 0 = No increase in muscle tone 1 = Slight increase in muscle tone 1+ = Minimal resistance through less than half of the range 2 = More marked increase in tone 3 = Considerable increase in tone 4 = Rigid in flexion or extension The assessment will be performed on the ankle plantar flexor muscles. Higher scores indicate greater spasticity (worse outcome), while lower scores indicate improvement.	Baseline, 4 weeks (post-treatment), and 8 weeks (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Walking Speed Assessed by 10-Meter Walk Test (10MWT)	The 10MWT measures walking speed over a short distance. Participants will be instructed to walk at a comfortable pace, and time will be recorded in seconds. Lower times indicate improved walking performance. Walking speed will be assessed using the 10-Meter Walk Test (10MWT). Participants will walk a 10-meter distance at a comfortable pace. Time will be recorded in seconds. There is no fixed minimum or maximum score; lower time indicates better walking performance.	Baseline, 4 weeks, 8 weeks
Change in Functional Mobility Assessed by Timed Up and Go Test (TUG)	The TUG test evaluates functional mobility. Participants will stand up from a chair, walk 3 meters, turn, walk back, and sit down. The time to complete the task will be recorded in seconds. Lower times indicate better mobility. Functional mobility will be assessed using the Timed Up and Go Test (TUG). Time (seconds) required to stand up, walk 3 meters, turn, return, and sit down will be recorded. There is no fixed minimum or maximum score; lower time indicates better mobility.	Baseline, 4 weeks, 8 weeks
Change in Motor Function Assessed by Fugl-Meyer Assessment - Lower Extremity (FMA-LE)	The FMA-LE assesses motor recovery after stroke, including reflexes, movement coordination, and voluntary control. Scores range from 0 to 34, with higher scores indicating better motor function. Motor function will be assessed using the Fugl-Meyer Assessment for Lower Extremity (FMA-LE). The total score ranges from 0 to 34, with: 0 = Severe impairment 34 = Normal motor function Higher scores indicate better motor function (better outcome).	Baseline, 4 weeks, 8 weeks
Change in Functional Exercise Capacity Assessed by 6-Minute Walk Test (6MWT)	The 6MWT measures the distance a participant can walk in six minutes. It reflects functional exercise capacity and endurance. Greater distances indicate better performance. Functional capacity will be assessed using the 6-Minute Walk Test (6MWT). Total walking distance (meters) in 6 minutes will be recorded. There is no fixed maximum; higher distance indicates better functional capacity. Time Frame: Baseline, 4 weeks, 8 weeks	Baseline, 4 weeks, 8 weeks
Change in Health-Related Quality of Life Assessed by Stroke-Specific Quality of Life Scale (SS-QOL)	The SS-QOL is a stroke-specific questionnaire assessing multiple domains including mobility, self-care, mood, and social participation. Higher scores indicate better quality of life. Quality of life will be assessed using the Stroke-Specific Quality of Life Scale (SS-QOL). The scale ranges from approximately 49 to 245, depending on scoring method. Higher scores indicate better quality of life (better outcome).	Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Spasticity; Extracorporeal Shock Wave; ESWT Stroke Rehabilitation; Mobility Fugl-Meyer
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Stroke; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: IMU-2026; IMU-2026 -STROKE (Other Identifier: IMU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 Sharing Time Frame: IPD and supporting information will be available starting 3 months after publication of the primary study results and will remain accessible for 5 years.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No