StrokeNCT07520032
Effectiveness of Extra-corporeal Shockwave Diathermy in the Management of Upper Limb Function Patients With Stroke.
A study testing ESWT, Stretching and Mobility in people with Stroke, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
Stroke is a leading cause of death and disability worldwide. A major complication of stroke is spasticity, marked by increased muscle tone and impaired movement. It affects majority stroke patients and complicates rehabilitation, affecting the upper limb function of survivors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- ESWT, Stretching and Mobility
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 30 Oct 2025to 30 Mar 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as 1st stroke incidence 6 months back
- Both male and female
- Age 25 to 65 years
- the ability to follow verbal instructions
- Modified Ashworth Scale score 1-4
Who cannot join
- Recurrent stroke.
- Severe contractures or deformities of upper extremity.
- Chronic pain affecting upper extremity function.
- malignant tumor, pacemakers, infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Gulf Medical University
Ajman, Ajman Emirate
Dr. Ramprasad Muthukrishnan, Ph.D, 971-555917250 ext. 1551, mrp@gmu.ac.ae
Sateesh Durairaj, PhD, 971-551808474
About this study
Official title: Effectiveness of Extra-corporeal Shockwave Diathermy in the Management of Upper Limb Function Patients With Stroke: Randomized Controlled Trial.
Stroke is a leading cause of death and disability worldwide. A major complication of stroke is spasticity, marked by increased muscle tone and impaired movement. It affects majority stroke patients and complicates rehabilitation, affecting the upper limb function of survivors.
While traditional treatments like oral medications and botulinum toxin injections offer some relief, they have notable limitations, causing the need for novel, non-invasive approaches. Extracorporeal shock wave therapy (ESWT), which uses acoustic waves for regeneration and neuromodulation, has shown promise in reducing spasticity with minimal side effects, though its precise mechanisms and ideal protocols need further study. Current evidence supports ESWT's efficacy and safety, often matching established treatments, but gaps remain regarding standardized application and long-term functional outcomes, highlighting the need for more robust research.
Read the detailed description
Stroke is one of the leading causes of mortality and long-term disability, with millions of new cases each year and a large proportion of survivors living with lasting impairments in movement and function. After a stroke, damage to the motor areas and descending pathways of the brain frequently leads to spasticity, a condition in which muscles become abnormally tight and resist passive stretch; this increase in muscle tone is velocity-dependent and often accompanied by weakness and loss of selective control. Spasticity develops in a substantial proportion of stroke survivors and is especially disabling when it involves the upper limb, where it interferes with reaching, grasping, releasing, and the performance of essential activities of daily living such as dressing, feeding, and personal care.
Upper limb involvement is particularly common because most strokes affect the middle cerebral artery (MCA) territory, which supplies key regions of the motor cortex and internal capsule responsible for control of the face and arm more than the leg. As a result, many patients present with the characteristic pattern of flexor spasticity in the shoulder, elbow, wrist, and fingers, while the lower limb may show relatively better recovery or a different pattern of impairment. Recovery of upper limb function is also typically slower and less complete than that of the lower limb: walking often returns earlier, whereas fine hand and arm movements require more complex cortical processing and richer sensorimotor integration, which are more vulnerable to damage and harder to reorganize. This slower recovery reflects, in part, the lower effective neuroplasticity or more limited spontaneous re-organization in upper limb networks after stroke, meaning that more intensive, targeted, and often multimodal interventions are needed to restore arm and hand function.
Because of these factors, the upper limb frequently remains a limitation for independence even when a patient can walk, and persistent spasticity in the arm can further block functional gains by causing abnormal postures, contractures, and pain. Traditional approaches to spasticity management; such as oral antispastic medications and botulinum toxin injections can reduce muscle tone, but they often provide only temporary relief, may have systemic or local side effects, and do not always translate into meaningful functional improvements. These limitations have driven interest in innovative, non-invasive options that can modulate muscle tone and support neuroplasticity while fitting into comprehensive rehabilitation programs.
Extracorporeal shock wave therapy (ESWT) is one such emerging modality as it delivers controlled acoustic waves to targeted muscles and soft tissues and is thought to act through a combination of mechanical, vascular, and neuromodulator mechanisms. Experimental and clinical studies suggest that ESWT may reduce spasticity by altering reflex excitability, influencing neuromuscular junction function, and promoting tissue regeneration and remodeling, with reported side effects generally mild and transient. Early and mid-term clinical evidence indicates that ESWT can safely decrease spasticity and, in some trials, achieve functional gains comparable to more established treatments, but the exact mechanisms, optimal parameters (energy, frequency, number of shocks, treatment sites, and session frequency), and long-term functional impact are not yet fully defined.
This study focuses on the upper limb spasticity as it is the region where disability is often greatest, recovery is slowest, and current options are imperfect. By targeting key flexor muscle groups of the affected upper limb with ESWT, the aim is to reduce pathological muscle overactivity and spasticity, thereby creating a more favorable biomechanical and neurophysiological environment for active training and functional use. The study plan hypothesizes that systematically applied ESWT, integrated with structured rehabilitation, can meaningfully improve upper limb function in stroke, addressing a critical unmet need in post-stroke care and contributing evidence toward standardized, parameter-based ESWT protocols.
- Conditions
- Stroke
- Being tested
- ESWT, Stretching, Mobility, Strengthening, Functional training
- Keywords
- upperlimb funciton, extracarporal shockwave therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWTOther
Target muscles: biceps brachii, flexor carpi radialis, pronator teres, wrist and finger flexors.
Protocol: 2000 shocks per muscle per session, energy flux density 0.03 mJ/mm², frequency 8 Hz, pressure ~0.2 MPa (2 bars).(1)
StretchingOther
Sustained stretches held for 10 seconds, 3-5 repetitions per muscle group
MobilityOther
Active and passive range of motion (ROM) exercises, 10-15 reps
StrengtheningOther
Isometric/ Isotonic exercises for antagonist muscles, 3 sets of 10-15 reps
Functional trainingOther
Task-oriented activities ADLs. Eg: grasping, reaching, manipulation, 20-30 minutes per session
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants randomized in to experimental group will receive Extra-corporeal Shockwave therapy applied to the spastic upper limb muscles along with conventional upper limb physiotherapy program. Receives: Other: ESWT; Other: Stretching; Other: Mobility; Other: Strengthening; Other: Functional training |
| Control group | Sham comparator | Participants randomized in to control group will receive sham Extra-corporeal Shockwave therapy applied to the spastic upper limb muscles along with conventional upper limb physiotherapy program. Receives: Other: Stretching; Other: Mobility; Other: Strengthening; Other: Functional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb function test
The upper limb function will be evaluated using the Neofect Smart Board test. The test will involve three different kinematic assessment programs: free exploration, point-to-point reaching, and circle-drawing.Data will be recorded as time taken to complete the evaluation (s) then the average of three tasks will serve to denote the upperlimb function. Each assessment program has a time limit of 60 s. (2)
Measured: Baseline, post intervention (6 week), 1 month followup (10 weeks)
Secondary outcomes (2)
Electrical activation of muscle
Muscle activity will be objectively assessed using using the BTS, Electromyography (EMG) system to measure amplitude of root mean square (RMS) (µV).(3) RMS reflects the overall level at rest and during movement.The subject will be asked to be seated comfortably on a chair with his/her arm rested on a table, elbow extension at 110°-120°, and the wrist placed in the neutral position. The subject will be requested four motion patterns spherical grasp, hand opening, tripod pinch , and hook grip. Each movement will be performed 3 times in pair, for accuracy.
During this process six EMG sensors will placed on the six muscles: flexor digitorum superficialis (FDS), flexor digitorum Profundus (FDP), medial head of extensor digitorum (EDM), lateral head of extensor digitorum (EDL), extensor pollicis longus (EPL), and extensor carpi radialis longus (ECR) muscle on the tested side.(3)
Measured: Baseline, post intervention (6 week), 1 month followup (10 weeks)
Muscles force generating capacity
Muscle's highest force-generating capacity during voluntary effort will be recorded with maximum voluntary contraction (MVC) (expressed as %).(3). The subject will be asked to follow the same EMG procedure denoted for recording the overall electrical activity of the muscle. Except in each pair of movement, one movement will be performed at maximum voluntary contraction (MVC) and the other one at comfortable force.
Measured: Baseline, post intervention (6 week), 1 month followup (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start30 Oct 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharmila banu Ali, DPT/MPT, Principal investigator, Thumbay Physical Therapy and Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520032
- Sponsor's protocol ID
- IRB-COHS-FAC-57-Jan-2026
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park M, Ko MH, Oh SW, Lee JY, Ham Y, Yi H, Choi Y, Ha D, Shin JH. Effects of virtual reality-based planar motion exercises on upper extremity function, range of motion, and health-related quality of life: a multicenter, single-blinded, randomized, controlled pilot study. J Neuroeng Rehabil. 2019 Oct 24;16(1):122. doi: 10.1186/s12984-019-0595-8.
PubMed 31651335Duan H, Lian Y, Jing Y, Xing J, Li Z. Research progress in extracorporeal shock wave therapy for upper limb spasticity after stroke. Front Neurol. 2023 Feb 9;14:1121026. doi: 10.3389/fneur.2023.1121026. eCollection 2023.
PubMed 36846123Silverman JD, Balbinot G, Masani K, Zariffa J, Eng P. Validity and Reliability of Surface Electromyography Features in Lower Extremity Muscle Contraction in Healthy and Spinal Cord-Injured Participants. Top Spinal Cord Inj Rehabil. 2021 Fall;27(4):14-27. doi: 10.46292/sci20-00001. Epub 2021 Feb 8.
PubMed 34866885
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extra-corporeal Shockwave Diathermy in the Management of Upper Limb Function Patients With Stroke: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07520032
- Acronym / sponsor ID
- IRB-COHS-FAC-57-Jan-2026
- Conditions
- Stroke
- Keywords
- upperlimb funciton, extracarporal shockwave therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 9 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.
Stroke is a leading cause of death and disability worldwide. A major complication of stroke is spasticity, marked by increased muscle tone and impaired movement. It affects majority stroke patients and complicates rehabilitation, affecting the upper limb function of survivors.
While traditional treatments like oral medications and botulinum toxin injections offer some relief, they have notable limitations, causing the need for novel, non-invasive approaches. Extracorporeal shock wave therapy (ESWT), which uses acoustic waves for regeneration and neuromodulation, has shown promise in reducing spasticity with minimal side effects, though its precise mechanisms and ideal protocols need further study. Current evidence supports ESWT's efficacy and safety, often matching established treatments, but gaps remain regarding standardized application and long-term functional outcomes, highlighting the need for more robust research.
Detailed description
Stroke is one of the leading causes of mortality and long-term disability, with millions of new cases each year and a large proportion of survivors living with lasting impairments in movement and function. After a stroke, damage to the motor areas and descending pathways of the brain frequently leads to spasticity, a condition in which muscles become abnormally tight and resist passive stretch; this increase in muscle tone is velocity-dependent and often accompanied by weakness and loss of selective control. Spasticity develops in a substantial proportion of stroke survivors and is especially disabling when it involves the upper limb, where it interferes with reaching, grasping, releasing, and the performance of essential activities of daily living such as dressing, feeding, and personal care.
Upper limb involvement is particularly common because most strokes affect the middle cerebral artery (MCA) territory, which supplies key regions of the motor cortex and internal capsule responsible for control of the face and arm more than the leg. As a result, many patients present with the characteristic pattern of flexor spasticity in the shoulder, elbow, wrist, and fingers, while the lower limb may show relatively better recovery or a different pattern of impairment. Recovery of upper limb function is also typically slower and less complete than that of the lower limb: walking often returns earlier, whereas fine hand and arm movements require more complex cortical processing and richer sensorimotor integration, which are more vulnerable to damage and harder to reorganize. This slower recovery reflects, in part, the lower effective neuroplasticity or more limited spontaneous re-organization in upper limb networks after stroke, meaning that more intensive, targeted, and often multimodal interventions are needed to restore arm and hand function.
Because of these factors, the upper limb frequently remains a limitation for independence even when a patient can walk, and persistent spasticity in the arm can further block functional gains by causing abnormal postures, contractures, and pain. Traditional approaches to spasticity management; such as oral antispastic medications and botulinum toxin injections can reduce muscle tone, but they often provide only temporary relief, may have systemic or local side effects, and do not always translate into meaningful functional improvements. These limitations have driven interest in innovative, non-invasive options that can modulate muscle tone and support neuroplasticity while fitting into comprehensive rehabilitation programs.
Extracorporeal shock wave therapy (ESWT) is one such emerging modality as it delivers controlled acoustic waves to targeted muscles and soft tissues and is thought to act through a combination of mechanical, vascular, and neuromodulator mechanisms. Experimental and clinical studies suggest that ESWT may reduce spasticity by altering reflex excitability, influencing neuromuscular junction function, and promoting tissue regeneration and remodeling, with reported side effects generally mild and transient. Early and mid-term clinical evidence indicates that ESWT can safely decrease spasticity and, in some trials, achieve functional gains comparable to more established treatments, but the exact mechanisms, optimal parameters (energy, frequency, number of shocks, treatment sites, and session frequency), and long-term functional impact are not yet fully defined.
This study focuses on the upper limb spasticity as it is the region where disability is often greatest, recovery is slowest, and current options are imperfect. By targeting key flexor muscle groups of the affected upper limb with ESWT, the aim is to reduce pathological muscle overactivity and spasticity, thereby creating a more favorable biomechanical and neurophysiological environment for active training and functional use. The study plan hypothesizes that systematically applied ESWT, integrated with structured rehabilitation, can meaningfully improve upper limb function in stroke, addressing a critical unmet need in post-stroke care and contributing evidence toward standardized, parameter-based ESWT protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: ESWT, Other: Stretching, Other: Mobility, Other: Strengthening, Other: Functional trainingParticipants randomized in to experimental group will receive Extra-corporeal Shockwave therapy applied to the spastic upper limb muscles along with conventional upper limb physiotherapy program. |
| Control group | Sham comparator | Other: Stretching, Other: Mobility, Other: Strengthening, Other: Functional trainingParticipants randomized in to control group will receive sham Extra-corporeal Shockwave therapy applied to the spastic upper limb muscles along with conventional upper limb physiotherapy program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed as 1st stroke incidence 6 months back
- Both male and female
- Age 25 to 65 years
- the ability to follow verbal instructions
- Modified Ashworth Scale score 1-4
Key exclusion criteria (4 listed)
- Recurrent stroke.
- Severe contractures or deformities of upper extremity.
- Chronic pain affecting upper extremity function.
- malignant tumor, pacemakers, infection
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 |
|---|---|---|
| ESWTTarget muscles: biceps brachii, flexor carpi radialis, pronator teres, wrist and finger flexors. Protocol: 2000 shocks per muscle per session, energy flux density 0.03 mJ/mm², frequency 8 Hz, pressure ~0.2 MPa (2 bars).(1) | Other | Experimental group |
| StretchingSustained stretches held for 10 seconds, 3-5 repetitions per muscle group | Other | Control group, Experimental group |
| MobilityActive and passive range of motion (ROM) exercises, 10-15 reps | Other | Control group, Experimental group |
| StrengtheningIsometric/ Isotonic exercises for antagonist muscles, 3 sets of 10-15 reps | Other | Control group, Experimental group |
| Functional trainingTask-oriented activities ADLs. Eg: grasping, reaching, manipulation, 20-30 minutes per session | Other | Control group, Experimental group |
Primary outcome
Upper limb function test
Time frame: Baseline, post intervention (6 week), 1 month followup (10 weeks)
The upper limb function will be evaluated using the Neofect Smart Board test. The test will involve three different kinematic assessment programs: free exploration, point-to-point reaching, and circle-drawing.Data will be recorded as time taken to complete the evaluation (s) then the average of three tasks will serve to denote the upperlimb function. Each assessment program has a time limit of 60 s. (2)
2 secondary outcomes
Electrical activation of muscle
Time frame: Baseline, post intervention (6 week), 1 month followup (10 weeks)
Muscles force generating capacity
Time frame: Baseline, post intervention (6 week), 1 month followup (10 weeks)
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 24 Sep 2026.
- Background: PubMed 31651335Park M, Ko MH, Oh SW, Lee JY, Ham Y, Yi H, Choi Y, Ha D, Shin JH. Effects of virtual reality-based planar motion exercises on upper extremity function, range of motion, and health-related quality of life: a multicenter, single-blinded, randomized, controlled pilot study. J Neuroeng Rehabil. 2019 Oct 24;16(1):122. doi: 10.1186/s12984-019-0595-8.
- Background: PubMed 36846123Duan H, Lian Y, Jing Y, Xing J, Li Z. Research progress in extracorporeal shock wave therapy for upper limb spasticity after stroke. Front Neurol. 2023 Feb 9;14:1121026. doi: 10.3389/fneur.2023.1121026. eCollection 2023.
- Background: PubMed 34866885Silverman JD, Balbinot G, Masani K, Zariffa J, Eng P. Validity and Reliability of Surface Electromyography Features in Lower Extremity Muscle Contraction in Healthy and Spinal Cord-Injured Participants. Top Spinal Cord Inj Rehabil. 2021 Fall;27(4):14-27. doi: 10.46292/sci20-00001. Epub 2021 Feb 8.
- 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.
Sharmila banu Ali, DPT/MPT principal investigator
Thumbay Physical Therapy and Rehabilitation 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 ESWT, Stretching and Mobility in people with Stroke, run by Gulf Medical University at 1 site in United Arab Emirates.
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 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: looking for participants now, as of the sponsor's last update on 24 Sep 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 United Arab Emirates. 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?
Contact Sharmila banu Ali, DPT (067031555 ext. 1906, sharmieashak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb function test (time frame: Baseline, post intervention (6 week), 1 month followup (10 weeks)). 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 NCT07520032, which also lists 3 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 24 Sep 2026.