StrokeNCT06365476
FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity
A study testing focused extracorporeal shock wave therapy (ESWT) in people with Stroke and Spasticity, Muscle, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Spasticity, Muscle
- What is being tested?
- focused 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
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Mar 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Individuals aged 18 years or older with unilateral cerebral stroke.
- Wrist and finger flexor muscle tone with a score greater than 1 on the Modified Ashworth Scale.
- Stable medical condition and vital signs.
- Conscious and able to comply with instructions.
Who cannot join
- History of more than one stroke, traumatic brain injury, or cerebral neoplasm.
- Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal diseases affecting muscle tone assessment.
- Contraindications for shockwave intervention, such as malignancies, coagulopathies, local infections, or use of cardiac pacemakers.
- Undergone shockwave therapy or botulinum toxin injections for post-stroke spasticity in the past three months.
- Cognitive, consciousness, or language impairments preventing participation in the intervention or functional assessments.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
Taipei, Taipei, 100
About this study
Official title: Effects of Extracorporeal Shock Wave for Upper Limb Flexor Spasticity in Stroke Patients: A Randomized Controlled Trial
Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.
Read the detailed description
This study aimed to evaluate the effects of focused Extracorporeal Shock Wave Therapy (ESWT) on upper limb flexor spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific forearm flexor muscles, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.
The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, hand grip strength, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, ultrasound strain elastography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on upper limb function and spasticity in stroke survivors.
- Conditions
- Stroke, Spasticity, Muscle
- Being tested
- focused extracorporeal shock wave therapy (ESWT)
- Keywords
- stroke, spasticity, shock wave, wrist, finger
- 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.
focused extracorporeal shock wave therapy (ESWT)Device
The focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis.
| Study group | Role | What they receive |
|---|---|---|
| Focused Extracorporeal Shock Wave Therapy | Experimental | Participants in this arm will receive focused Extracorporeal Shock Wave Therapy (ESWT) targeting three specific muscles: the flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis. Each muscle will receive 1,500 shockwave shots per session, accumulating to a total of 4,500 shots across all targeted muscles in each session. The treatment will be administered twice a week for two consecutive weeks, resulting in a total of four treatment sessions. Receives: Device: focused extracorporeal shock wave therapy (ESWT) |
| Placebo-Controlled Shockwave Therapy | Placebo comparator | Participants in this arm will receive placebo-controlled focused ESWT, mirroring the treatment protocol of the experimental group but without the application of active shockwaves. Receives: Device: focused extracorporeal shock wave therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Ashworth scale (MAS)
Evaluate spasticity in individuals with neurological conditions. The scale ranges from 0, indicating no increase in muscle tone, to 4, which represents severe spasticity with affected parts rigid in flexion or extension.
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Secondary outcomes (11)
modified Tardieu scale (MTS) R2-R1 Angle
Difference between passive range of motion (R2) and the angle of muscle catch (R1), measured in degrees. Larger values indicate greater dynamic spasticity.
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Tardieu grade
Spasticity severity (0-5); higher grades indicate greater spasticity.
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
passive range of motion for the wrist and finger joints
the extent to which a joint can be moved without the patient actively participating in the movement
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Medical Research Council (MRC) scale
grades voluntary muscle strength on a 0-5 ordinal scale
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
hand grip strength
use dynamometer to record the maximum force applied when the patient squeezes it
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Barthel index
measures a person's daily living abilities, focusing on ten areas of self-care and mobility. Scores range from 0 to 100, with higher scores denoting greater independence.
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Functional Independence Measure (FIM)
assesses a patient's level of disability and tracks changes over time, with a focus on physical and cognitive functioning across 18 items, scored from 18 (total assistance required) to 126 (fully independent).
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Wolf Motor Function Test (WMFT) Functional ability score
assess upper extremity function in individuals with neurological impairments, using 15 functional tasks. Scoring is on a 6-point ordinal scale, ranging from 0 ("Does not attempt with upper extremity being tested," indicating severe impairment) to 5 ("Movement appears to be normal," suggesting full functionality). Lower scores indicate greater impairment.
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Action Research Arm Test (ARAT)
a standardized measure evaluating upper limb motor ability in stroke patients, scoring from 0 (no movement) to 57 (normal arm function). It assesses grasp, grip, pinch, and gross arm movement.
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
range from 0 (complete paralysis) to 66 (full function), assessing motor recovery in post-stroke upper extremities
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
ultrasound assessment
used strain elastography to assess elasticity of forearm muscles
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start22 Mar 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-mei Yang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365476
- Sponsor's protocol ID
- 202309126RIND
- Status last verified
- Nov 2025
- First submitted
- 9 Apr 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dymarek R, Taradaj J, Rosinczuk J. Extracorporeal Shock Wave Stimulation as Alternative Treatment Modality for Wrist and Fingers Spasticity in Poststroke Patients: A Prospective, Open-Label, Preliminary Clinical Trial. Evid Based Complement Alternat Med. 2016;2016:4648101. doi: 10.1155/2016/4648101. Epub 2016 Jul 18.
PubMed 27504139Cabanas-Valdes R, Calvo-Sanz J, Urrutia G, Serra-Llobet P, Perez-Bellmunt A, German-Romero A. The effectiveness of extracorporeal shock wave therapy to reduce lower limb spasticity in stroke patients: a systematic review and meta-analysis. Top Stroke Rehabil. 2020 Mar;27(2):137-157. doi: 10.1080/10749357.2019.1654242. Epub 2019 Nov 11.
PubMed 31710277Yasar E, Adiguzel E, Kesikburun S, Yenihayat I, Yilmaz B, Alaca R, Tan AK. Assessment of forearm muscle spasticity with sonoelastography in patients with stroke. Br J Radiol. 2016 Dec;89(1068):20160603. doi: 10.1259/bjr.20160603. Epub 2016 Oct 25.
PubMed 27679870Jia G, Ma J, Wang S, Wu D, Tan B, Yin Y, Jia L, Cheng L. Long-term Effects of Extracorporeal Shock Wave Therapy on Poststroke Spasticity: A Meta-analysis of Randomized Controlled Trials. J Stroke Cerebrovasc Dis. 2020 Mar;29(3):104591. doi: 10.1016/j.jstrokecerebrovasdis.2019.104591. Epub 2019 Dec 31.
PubMed 31899073
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extracorporeal Shock Wave for Upper Limb Flexor Spasticity in Stroke Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06365476
- Acronym / sponsor ID
- 202309126RIND
- Conditions
- Stroke, Spasticity, Muscle
- Keywords
- stroke, spasticity, shock wave, wrist, finger
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Apr 2024 (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.
Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.
Detailed description
This study aimed to evaluate the effects of focused Extracorporeal Shock Wave Therapy (ESWT) on upper limb flexor spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific forearm flexor muscles, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.
The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, hand grip strength, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, ultrasound strain elastography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on upper limb function and spasticity in stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused Extracorporeal Shock Wave Therapy | Experimental | Device: focused extracorporeal shock wave therapy (ESWT)Participants in this arm will receive focused Extracorporeal Shock Wave Therapy (ESWT) targeting three specific muscles: the flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis. Each muscle will receive 1,500 shockwave shots per session, accumulating to a total of 4,500 shots across all targeted muscles in each session. The treatment will be administered twice a week for two consecutive weeks, resulting in a total of four treatment sessions. |
| Placebo-Controlled Shockwave Therapy | Placebo comparator | Device: focused extracorporeal shock wave therapy (ESWT)Participants in this arm will receive placebo-controlled focused ESWT, mirroring the treatment protocol of the experimental group but without the application of active shockwaves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 18 years or older with unilateral cerebral stroke.
- Wrist and finger flexor muscle tone with a score greater than 1 on the Modified Ashworth Scale.
- Stable medical condition and vital signs.
- Conscious and able to comply with instructions.
Key exclusion criteria (5 listed)
- History of more than one stroke, traumatic brain injury, or cerebral neoplasm.
- Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal diseases affecting muscle tone assessment.
- Contraindications for shockwave intervention, such as malignancies, coagulopathies, local infections, or use of cardiac pacemakers.
- Undergone shockwave therapy or botulinum toxin injections for post-stroke spasticity in the past three months.
- Cognitive, consciousness, or language impairments preventing participation in the intervention or functional assessments.
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 |
|---|---|---|
| focused extracorporeal shock wave therapy (ESWT)The focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis. | Device | Focused Extracorporeal Shock Wave Therapy, Placebo-Controlled Shockwave Therapy |
Primary outcome
modified Ashworth scale (MAS)
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Evaluate spasticity in individuals with neurological conditions. The scale ranges from 0, indicating no increase in muscle tone, to 4, which represents severe spasticity with affected parts rigid in flexion or extension.
11 secondary outcomes
modified Tardieu scale (MTS) R2-R1 Angle
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Tardieu grade
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
passive range of motion for the wrist and finger joints
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Medical Research Council (MRC) scale
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
hand grip strength
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Barthel index
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Functional Independence Measure (FIM)
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Wolf Motor Function Test (WMFT) Functional ability score
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Action Research Arm Test (ARAT)
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
ultrasound assessment
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Results publication: PubMed 27504139Dymarek R, Taradaj J, Rosinczuk J. Extracorporeal Shock Wave Stimulation as Alternative Treatment Modality for Wrist and Fingers Spasticity in Poststroke Patients: A Prospective, Open-Label, Preliminary Clinical Trial. Evid Based Complement Alternat Med. 2016;2016:4648101. doi: 10.1155/2016/4648101. Epub 2016 Jul 18.
- Results publication: PubMed 31710277Cabanas-Valdes R, Calvo-Sanz J, Urrutia G, Serra-Llobet P, Perez-Bellmunt A, German-Romero A. The effectiveness of extracorporeal shock wave therapy to reduce lower limb spasticity in stroke patients: a systematic review and meta-analysis. Top Stroke Rehabil. 2020 Mar;27(2):137-157. doi: 10.1080/10749357.2019.1654242. Epub 2019 Nov 11.
- Results publication: PubMed 27679870Yasar E, Adiguzel E, Kesikburun S, Yenihayat I, Yilmaz B, Alaca R, Tan AK. Assessment of forearm muscle spasticity with sonoelastography in patients with stroke. Br J Radiol. 2016 Dec;89(1068):20160603. doi: 10.1259/bjr.20160603. Epub 2016 Oct 25.
- Results publication: PubMed 31899073Jia G, Ma J, Wang S, Wu D, Tan B, Yin Y, Jia L, Cheng L. Long-term Effects of Extracorporeal Shock Wave Therapy on Poststroke Spasticity: A Meta-analysis of Randomized Controlled Trials. J Stroke Cerebrovasc Dis. 2020 Mar;29(3):104591. doi: 10.1016/j.jstrokecerebrovasdis.2019.104591. Epub 2019 Dec 31.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
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.
Shu-mei Yang, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focused extracorporeal shock wave therapy (ESWT) in people with Stroke and Spasticity, Muscle, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
modified Ashworth scale (MAS) (time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06365476, which also lists 4 linked publications.
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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.