StrokeESWT-STROKENCT07523243
Effect of Extracorporeal Shock Wave Therapy on Spasticity and Mobility in Stroke Patients
A study testing Extracorporeal Shock Wave Therapy (ESWT) in people with Stroke and Post-Stroke Spasticity, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Post-Stroke Spasticity, Lower Limb Spasticity
- What is being tested?
- Extracorporeal Shock Wave Therapy (ESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2026to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Stroke, Post-Stroke Spasticity, Lower Limb Spasticity
- Being tested
- Extracorporeal Shock Wave Therapy (ESWT), Sham Extracorporeal Shock Wave Therapy
- Keywords
- Extracorporeal Shock Wave, ESWT Stroke Rehabilitation, Mobility Fugl-Meyer, Quality of Life, Spasticity
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave Therapy (ESWT)Device
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 Extracorporeal Shock Wave TherapyDevice
A sham ESWT procedure will be performed using the same device without energy transmission, mimicking the sound and sensation of treatment.
| Study group | Role | What they receive |
|---|---|---|
| ESWT Group | Experimental | 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. Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Control Group (Sham ESWT) | Sham comparator | Participants in this group will receive sham ESWT with no therapeutic energy delivery in addition to the same standard physiotherapy program. Receives: Device: Sham Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks (post-treatment)
Secondary outcomes (5)
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.
Measured: Baseline, 4 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.
Measured: Baseline, 4 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).
Measured: Baseline, 4 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.
Measured: Baseline, 4 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).
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start10 Apr 2026
- Primary completion30 Apr 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: an intervention group receiving extracorporeal shock wave therapy (ESWT) in addition to standard physiotherapy, and a control group receiving sham ESWT along with the same physiotherapy program. Outcomes will be compared between groups over time.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, salih tan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523243
- Sponsor's protocol ID
- IMU-2026
- Other IDs
- IMU-2026 -STROKE
- Acronym
- ESWT-STROKE
- Status last verified
- Jan 2026
- First submitted
- 4 Apr 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07523243
- Acronym / sponsor ID
- ESWT-STROKE / IMU-2026
- Conditions
- Stroke, Post-Stroke Spasticity, Lower Limb Spasticity
- Keywords
- Extracorporeal Shock Wave, ESWT Stroke Rehabilitation, Mobility Fugl-Meyer, Quality of Life, Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: an intervention group receiving extracorporeal shock wave therapy (ESWT) in addition to standard physiotherapy, and a control group receiving sham ESWT along with the same physiotherapy program. Outcomes will be compared between groups over time.
| Arm | Type | Receives |
|---|---|---|
| ESWT Group | Experimental | Device: Extracorporeal Shock Wave Therapy (ESWT)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. |
| Control Group (Sham ESWT) | Sham comparator | Device: Sham Extracorporeal Shock Wave TherapyParticipants in this group will receive sham ESWT with no therapeutic energy delivery in addition to the same standard physiotherapy program. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-80 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ESWT Group |
| Sham Extracorporeal Shock Wave TherapyA sham ESWT procedure will be performed using the same device without energy transmission, mimicking the sound and sensation of treatment. | Device | Control Group (Sham ESWT) |
Primary outcome
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Time frame: Baseline, 4 weeks (post-treatment)
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.
5 secondary outcomes
Change in Walking Speed Assessed by 10-Meter Walk Test (10MWT)
Time frame: Baseline, 4 weeks
Change in Functional Mobility Assessed by Timed Up and Go Test (TUG)
Time frame: Baseline, 4 weeks
Change in Motor Function Assessed by Fugl-Meyer Assessment - Lower Extremity (FMA-LE)
Time frame: Baseline, 4 weeks
Change in Functional Exercise Capacity Assessed by 6-Minute Walk Test (6MWT)
Time frame: Baseline, 4 weeks
Change in Health-Related Quality of Life Assessed by Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: Baseline, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy (ESWT) in people with Stroke and Post-Stroke Spasticity, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spasticity Assessed by Modified Ashworth Scale (MAS) (time frame: Baseline, 4 weeks (post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.