StrokeNCT07532187
The Effects of Extracorporeal Shock Wave Therapy on Upper Extremity Spasticity and Function in Patients With Stroke
A study testing Radial Extracorporeal Shock Wave Therapy (rESWT) in people with Stroke, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Spasticity is a common complication after stroke and can limit upper extremity motor control and activities of daily living. Radial extracorporeal shock wave therapy (rESWT) is a non-invasive treatment that has been investigated for post-stroke spasticity; however, treatment protocols vary widely across studies in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Radial Extracorporeal Shock Wave Therapy (rESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 7 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of hemiplegia following stroke
- Minimum of 4 weeks elapsed since stroke onset
- Modified Ashworth Scale (MAS) score ≥ 2 for elbow or wrist spasticity
- Sufficient cognitive ability to follow simple commands
- No botulinum toxin injection in the preceding 3 months
- Willing to participate and signed informed consent form
Who cannot join
- Impaired consciousness or severe cognitive deficit
- Systemic conditions contraindicating ESWT (active infection, malignancy, etc.)
- Shoulder subluxation on the affected side
- Skin integrity disruption at the application site
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Istanbul, Istanbul, 34785
About this study
Official title: The Effects of Extracorporeal Shock Wave Therapy on Upper Extremity Spasticity and Function in Patients With Stroke: A Single-Arm Study
Spasticity is a common complication after stroke and can limit upper extremity motor control and activities of daily living. Radial extracorporeal shock wave therapy (rESWT) is a non-invasive treatment that has been investigated for post-stroke spasticity; however, treatment protocols vary widely across studies in the muscles treated, number of impulses, session frequency, energy parameters, and application sites. This prospective, single-center, single-arm study enrolled 30 adults with post-stroke hemiplegia and upper extremity spasticity to evaluate changes in clinical outcomes following an rESWT protocol with anatomically predefined target points. rESWT was applied to the biceps brachii, flexor carpi radialis, and flexor carpi ulnaris of the affected arm twice weekly for 4 weeks (8 sessions). Spasticity, upper extremity motor function, functional independence, quality of life, pain, depressive symptoms, and sensory findings were assessed at baseline, week 4, and week 12.
Read the detailed description
Rationale: Studies of extracorporeal shock wave therapy for post-stroke spasticity differ in target muscles, number of impulses, session frequency, energy parameters, and application sites, and recent reviews have noted that ESWT protocols are not standardized. This study was designed to describe clinical changes following a single, clearly defined and reproducible rESWT protocol with anatomically predefined target points.
Design and Setting: Prospective, single-center, single-arm, open-label interventional study conducted at the Physical Medicine and Rehabilitation Clinic of Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, İstanbul, Türkiye. All participants received the same intervention; there was no control or sham group.
Intervention: rESWT was delivered using a Modus ESWT device (İnceler Medikal, Ankara, Türkiye) to three muscles of the affected upper extremity: biceps brachii, flexor carpi radialis (FCR), and flexor carpi ulnaris (FCU). Each muscle received 2,000 impulses per session at a frequency of 5 Hz and a pressure of 1.5 bar (6,000 impulses per session in total). Treatment was administered twice weekly for 4 weeks, for a total of 8 sessions (48,000 impulses per participant). Target points were defined using anatomical reference lines based on the EUROMUSCULUS/USPRM spasticity approach: for the biceps brachii, 65% of the reference line between the coracoid process and the medial epicondyle; for the FCR, 35% of the reference line connecting the interepicondylar and interstyloid lines; and for the FCU, the 30% point on the ventral portion of the same reference line. Target sites were identified by palpation and marked on the skin before application, and coupling gel was used to ensure acoustic transmission. All applications were performed by a single operator according to the standardized protocol.
Concomitant Care: All participants had completed a conventional physiotherapy and rehabilitation program before rESWT. No physiotherapy or rehabilitation and no antispastic medication were given during the treatment and follow-up period.
Assessment Schedule: Assessments were performed at baseline (before the first rESWT session), week 4, and week 12. All Modified Ashworth Scale assessments were performed by the same investigator, who was not blinded.
Withdrawal: Participants who received botulinum toxin injections or started a physical therapy and rehabilitation program during the treatment or follow-up period, and participants who did not complete the rESWT sessions or the follow-up assessments, were withdrawn from the study.
Statistical Analysis: Of the 30 enrolled participants, 21 completed the full treatment course and all three assessments and were included in the analyses; missing data were not imputed. Changes across the three time points were analyzed with the Friedman test, and baseline-to-follow-up comparisons with the Wilcoxon signed-rank test, with Holm correction for multiple comparisons. Paired Hodges-Lehmann estimates with bootstrap 95% confidence intervals were calculated. No a priori sample size calculation was performed.
Ethics: The study was approved by the Ethics Committee of Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital (Decision No: 2025/214; Date: 11.06.2025) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
- Conditions
- Stroke
- Being tested
- Radial Extracorporeal Shock Wave Therapy (rESWT)
- Keywords
- rEswt, stroke, hemiplegia, spasticity, upper extremity, rehabilitation
- Medical subject headings
- Stroke, Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal Shock Wave Therapy (rESWT)Device
rESWT was delivered to the biceps brachii, flexor carpi radialis, and flexor carpi ulnaris of the affected upper extremity. Parameters: 2,000 impulses per muscle group, 5 Hz, 1.5 bar. Eight sessions administered twice weekly over 4 weeks. Anatomical target points were standardized according to the EUROMUSCULUS/USPRM guideline.
| Study group | Role | What they receive |
|---|---|---|
| Radial Extracorporeal Shock Wave Therapy (rESWT) | Experimental | Participants received radial extracorporeal shock wave therapy applied to three muscle groups of the affected upper extremity (biceps brachii, flexor carpi radialis, and flexor carpi ulnaris) at 2,000 impulses per muscle group, 5 Hz frequency, and 1.5 bar pressure, twice weekly for 4 weeks (8 sessions total) Receives: Device: Radial Extracorporeal Shock Wave Therapy (rESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Upper Extremity Spasticity Measured by the Modified Ashworth Scale
Spasticity is assessed using the Modified Ashworth Scale (MAS), an ordinal scale measuring resistance to passive movement. Each of seven upper extremity movements (elbow flexion, elbow extension, forearm pronation, forearm supination, wrist flexion, wrist extension, and finger flexion) is graded individually on a 0 to 4 scale, where 0 (minimum) indicates no increase in muscle tone and 4 (maximum) indicates the affected part is rigid. Higher scores indicate greater spasticity (worse outcome).
Measured: Baseline, at 4 weeks and 12 weeks follow-up
Change From Baseline in Fugl-Meyer Assessment Upper Extremity Motor Function Score
Upper extremity motor function is assessed using the motor function domain of the upper extremity section of the Fugl-Meyer Assessment of Motor Recovery After Stroke (FMA-UE). It consists of 33 items evaluating reflex activity, voluntary movement within and out of synergy, wrist and hand function, and coordination/speed, each scored from 0 (cannot perform) to 2 (performs fully). Total scores range from 0 (minimum) to 66 (maximum). Higher scores indicate better motor function (better outcome).
Measured: Baseline, at 4 weeks and 12 weeks follow-up
Secondary outcomes (5)
Change from baseline in functional independence
Functional independence is assessed using the Modified Barthel Index (MBI), which evaluates 10 activities of daily living. Total scores range from 0 to 100. Higher scores indicate greater independence (better outcome).
Measured: Baseline, at 4 weeks and at 12 weeks follow-up
Change From Baseline in Pain Intensity Measured by the Visual Analog Scale
Pain intensity in the affected upper extremity is assessed using the Visual Analog Scale (VAS) for pain, recorded as a single score. Scores range from 0 (minimum; no pain) to 10 (maximum; unbearable pain). Higher scores indicate greater pain intensity (worse outcome).
Measured: Baseline, at 4 weeks and at 12 weeks follow-up
Change from baseline in stroke-specific quality of life
Quality of life is assessed using the Stroke Specific Quality of Life Scale (SS-QOL), a 49-item instrument covering 12 domains, each item scored on a 1 to 5 Likert scale. Total scores range from 49 to 245. Higher scores indicate better quality of life (better outcome).
Measured: Baseline, at 4 weeks and at 12 weeks follow-up
Change from baseline in depressive symptom severity
Depressive symptom severity is assessed using the Beck Depression Inventory (BDI), a 21-item self-report scale with each item scored from 0 to 3. Total scores range from 0 to 63. Higher scores indicate greater depressive symptom severity (worse outcome).
Measured: Baseline, at 4 weeks, and at 12 weeks follow-up
Change from baseline in proprioception
Joint position sense of the affected upper extremity is assessed via standard clinical examination and categorized as intact, impaired, or not assessable.
Measured: Baseline, at 4 weeks and at 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Jul 2025
- Primary completion7 May 2026
- Study completion7 May 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received radial extracorporeal shock wave therapy (rESWT) applied to the affected upper extremity. rESWT was delivered to three muscle groups - biceps brachii, flexor carpi radialis, and flexor carpi ulnaris - at standardized anatomical target points defined according to the EUROMUSCULUS/USPRM guideline. Treatment parameters were 2,000 impulses per muscle group, 5 Hz frequency, and 1.5 bar pressure, administered twice weekly for 4 weeks (8 sessions total). No concurrent antispastic medication or botulinum toxin injection was permitted during the study period. Outcomes were assessed at three time points: baseline, week 4, and week 12.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532187
- Sponsor's protocol ID
- BLG-STROKE-2026
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Extracorporeal Shock Wave Therapy on Upper Extremity Spasticity and Function in Patients With Stroke: A Single-Arm Study
- ClinicalTrials.gov ID
- NCT07532187
- Acronym / sponsor ID
- BLG-STROKE-2026
- Conditions
- Stroke
- Keywords
- rEswt, stroke, hemiplegia, spasticity, upper extremity, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 15 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.
Spasticity is a common complication after stroke and can limit upper extremity motor control and activities of daily living. Radial extracorporeal shock wave therapy (rESWT) is a non-invasive treatment that has been investigated for post-stroke spasticity; however, treatment protocols vary widely across studies in the muscles treated, number of impulses, session frequency, energy parameters, and application sites. This prospective, single-center, single-arm study enrolled 30 adults with post-stroke hemiplegia and upper extremity spasticity to evaluate changes in clinical outcomes following an rESWT protocol with anatomically predefined target points. rESWT was applied to the biceps brachii, flexor carpi radialis, and flexor carpi ulnaris of the affected arm twice weekly for 4 weeks (8 sessions). Spasticity, upper extremity motor function, functional independence, quality of life, pain, depressive symptoms, and sensory findings were assessed at baseline, week 4, and week 12.
Detailed description
Rationale: Studies of extracorporeal shock wave therapy for post-stroke spasticity differ in target muscles, number of impulses, session frequency, energy parameters, and application sites, and recent reviews have noted that ESWT protocols are not standardized. This study was designed to describe clinical changes following a single, clearly defined and reproducible rESWT protocol with anatomically predefined target points.
Design and Setting: Prospective, single-center, single-arm, open-label interventional study conducted at the Physical Medicine and Rehabilitation Clinic of Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, İstanbul, Türkiye. All participants received the same intervention; there was no control or sham group.
Intervention: rESWT was delivered using a Modus ESWT device (İnceler Medikal, Ankara, Türkiye) to three muscles of the affected upper extremity: biceps brachii, flexor carpi radialis (FCR), and flexor carpi ulnaris (FCU). Each muscle received 2,000 impulses per session at a frequency of 5 Hz and a pressure of 1.5 bar (6,000 impulses per session in total). Treatment was administered twice weekly for 4 weeks, for a total of 8 sessions (48,000 impulses per participant). Target points were defined using anatomical reference lines based on the EUROMUSCULUS/USPRM spasticity approach: for the biceps brachii, 65% of the reference line between the coracoid process and the medial epicondyle; for the FCR, 35% of the reference line connecting the interepicondylar and interstyloid lines; and for the FCU, the 30% point on the ventral portion of the same reference line. Target sites were identified by palpation and marked on the skin before application, and coupling gel was used to ensure acoustic transmission. All applications were performed by a single operator according to the standardized protocol.
Concomitant Care: All participants had completed a conventional physiotherapy and rehabilitation program before rESWT. No physiotherapy or rehabilitation and no antispastic medication were given during the treatment and follow-up period.
Assessment Schedule: Assessments were performed at baseline (before the first rESWT session), week 4, and week 12. All Modified Ashworth Scale assessments were performed by the same investigator, who was not blinded.
Withdrawal: Participants who received botulinum toxin injections or started a physical therapy and rehabilitation program during the treatment or follow-up period, and participants who did not complete the rESWT sessions or the follow-up assessments, were withdrawn from the study.
Statistical Analysis: Of the 30 enrolled participants, 21 completed the full treatment course and all three assessments and were included in the analyses; missing data were not imputed. Changes across the three time points were analyzed with the Friedman test, and baseline-to-follow-up comparisons with the Wilcoxon signed-rank test, with Holm correction for multiple comparisons. Paired Hodges-Lehmann estimates with bootstrap 95% confidence intervals were calculated. No a priori sample size calculation was performed.
Ethics: The study was approved by the Ethics Committee of Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital (Decision No: 2025/214; Date: 11.06.2025) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received radial extracorporeal shock wave therapy (rESWT) applied to the affected upper extremity. rESWT was delivered to three muscle groups - biceps brachii, flexor carpi radialis, and flexor carpi ulnaris - at standardized anatomical target points defined according to the EUROMUSCULUS/USPRM guideline. Treatment parameters were 2,000 impulses per muscle group, 5 Hz frequency, and 1.5 bar pressure, administered twice weekly for 4 weeks (8 sessions total). No concurrent antispastic medication or botulinum toxin injection was permitted during the study period. Outcomes were assessed at three time points: baseline, week 4, and week 12.
| Arm | Type | Receives |
|---|---|---|
| Radial Extracorporeal Shock Wave Therapy (rESWT) | Experimental | Device: Radial Extracorporeal Shock Wave Therapy (rESWT)Participants received radial extracorporeal shock wave therapy applied to three muscle groups of the affected upper extremity (biceps brachii, flexor carpi radialis, and flexor carpi ulnaris) at 2,000 impulses per muscle group, 5 Hz frequency, and 1.5 bar pressure, twice weekly for 4 weeks (8 sessions total) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Diagnosis of hemiplegia following stroke
- Minimum of 4 weeks elapsed since stroke onset
- Modified Ashworth Scale (MAS) score ≥ 2 for elbow or wrist spasticity
- Sufficient cognitive ability to follow simple commands
Key exclusion criteria (4 listed)
- Impaired consciousness or severe cognitive deficit
- Systemic conditions contraindicating ESWT (active infection, malignancy, etc.)
- Shoulder subluxation on the affected side
- Skin integrity disruption at the application site
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 |
|---|---|---|
| Radial Extracorporeal Shock Wave Therapy (rESWT)rESWT was delivered to the biceps brachii, flexor carpi radialis, and flexor carpi ulnaris of the affected upper extremity. Parameters: 2,000 impulses per muscle group, 5 Hz, 1.5 bar. Eight sessions administered twice weekly over 4 weeks. Anatomical target points were standardized according to the EUROMUSCULUS/USPRM guideline. | Device | Radial Extracorporeal Shock Wave Therapy (rESWT) |
Primary outcome
Change From Baseline in Upper Extremity Spasticity Measured by the Modified Ashworth Scale
Time frame: Baseline, at 4 weeks and 12 weeks follow-up
Spasticity is assessed using the Modified Ashworth Scale (MAS), an ordinal scale measuring resistance to passive movement. Each of seven upper extremity movements (elbow flexion, elbow extension, forearm pronation, forearm supination, wrist flexion, wrist extension, and finger flexion) is graded individually on a 0 to 4 scale, where 0 (minimum) indicates no increase in muscle tone and 4 (maximum) indicates the affected part is rigid. Higher scores indicate greater spasticity (worse outcome).
Change From Baseline in Fugl-Meyer Assessment Upper Extremity Motor Function Score
Time frame: Baseline, at 4 weeks and 12 weeks follow-up
Upper extremity motor function is assessed using the motor function domain of the upper extremity section of the Fugl-Meyer Assessment of Motor Recovery After Stroke (FMA-UE). It consists of 33 items evaluating reflex activity, voluntary movement within and out of synergy, wrist and hand function, and coordination/speed, each scored from 0 (cannot perform) to 2 (performs fully). Total scores range from 0 (minimum) to 66 (maximum). Higher scores indicate better motor function (better outcome).
5 secondary outcomes
Change from baseline in functional independence
Time frame: Baseline, at 4 weeks and at 12 weeks follow-up
Change From Baseline in Pain Intensity Measured by the Visual Analog Scale
Time frame: Baseline, at 4 weeks and at 12 weeks follow-up
Change from baseline in stroke-specific quality of life
Time frame: Baseline, at 4 weeks and at 12 weeks follow-up
Change from baseline in depressive symptom severity
Time frame: Baseline, at 4 weeks, and at 12 weeks follow-up
Change from baseline in proprioception
Time frame: Baseline, at 4 weeks and at 12 weeks follow-up
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 21 Oct 2026.
- Individual participant dataSharing planned: No
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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 Radial Extracorporeal Shock Wave Therapy (rESWT) in people with Stroke, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research 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 7 inclusion and 4 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 21 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. 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 From Baseline in Upper Extremity Spasticity Measured by the Modified Ashworth Scale (time frame: Baseline, at 4 weeks and 12 weeks follow-up). The study lists 2 primary outcomes in all. 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 21 Oct 2026.