StrokeNCT07119801
Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity
A study testing Radial Extracorporeal Shock Wave Therapy and Conventional rehabilitation in people with Stroke and Spastic Hemiplegia, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This research evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) for treating spasticity in the wrist flexor muscles (flexor carpi ulnaris - FCU and flexor carpi radialis - FCR) of chronic stroke patients. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Stroke, Spastic Hemiplegia, Extracorporal Shockwave Therapy (ESWT)
- What is being tested?
- Radial Extracorporeal Shock Wave Therapy and Conventional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2025to 20 Dec 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 35 and 65 years.
- First-ever stroke episode confirmed by MRI and/or CT scan.
- Clinical diagnosis of hemiplegia.
- More than 6 months post-stroke.
- A Modified Ashworth Scale (MAS) score between 1 and 3 for wrist flexor spasticity.
Who cannot join
- History of more than one stroke episode
- Stroke onset more than ten years ago
- Stroke onset less than 6 months ago
- Age over 65 (to limit the effects of aging on muscle structure)
- Contraindications for ESWT (e.g., cancer, local tumor or active infection in the treatment area, pregnancy, coagulation disorders, pacemaker or other electronic/metallic implants)
- Severe aphasia or serious communication problems
Show all 9Show fewer
- Presence of fixed contracture in the wrist
- Patients who have received botulinum toxin or phenol nerve block injections within the last 6 months
- Medically unstable patients (e.g., uncontrolled hypertension, diabetes mellitus, or severe cardiac, hepatic, or renal disease)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli
Atakan Yenidünya, Resident physician, +905373303225, tknyndny@gmail.com
About this study
Official title: Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity: A Randomized Controlled Trial
This research evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) for treating spasticity in the wrist flexor muscles (flexor carpi ulnaris - FCU and flexor carpi radialis - FCR) of chronic stroke patients.
Spasticity, a common complication after a stroke, causes muscle stiffness, pain, and functional limitation, leading to increased healthcare costs and a lower quality of life. Current treatments like medication and injections have significant drawbacks, such as side effects and high costs, creating a need for new, non-invasive, and effective methods.
Read more
The study highlights that traditional methods for assessing spasticity, like the Modified Ashworth Scale (MAS), are subjective. It proposes using objective, non-invasive ultrasound techniques-specifically strain elastography (to measure muscle stiffness) and echogenicity (to assess muscle tissue quality)-for a more reliable evaluation.
The primary goal of this research is to be the first to investigate the short- and long-term effects of ESWT on the FCR and FCU muscles using these objective ultrasound measures alongside traditional clinical scales. The findings are expected to help standardize ESWT treatment protocols and promote the use of objective ultrasound data for the management and follow-up of post-stroke spasticity.
- Being tested
- Radial Extracorporeal Shock Wave Therapy, Conventional rehabilitation
- Keywords
- spastic hemiplegia, extracorporeal shockwave therapy, spasticity of the wrist flexors
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal Shock Wave TherapyDevice
rESWT will be administered to the FCU and FCR muscles two days per week over a period of four weeks (8 sessions in total). The point of application will be selected as the center of the muscle belly for both the FCU and FCR. Each muscle will receive 2000 shocks using a 15 mm applicator tip at a frequency of 5 Hz. The treatment will be conducted at an intensity of 60 mJ (1 bar), with an energy flux density of 0.340 mJ/mm².
Conventional rehabilitationOther
Conventional rehabilitation will be administered for 1-2 hours daily, 5 days a week, for 12 weeks. It will include range of motion exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight shifting, balance, gait training, occupational therapy, and speech-language therapy according to the patient's needs.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Active comparator | This group will receive physical therapy for 1-2 hours daily, 5 days a week, for 12 weeks. The therapy will include range of motion (ROM) exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-bearing exercises, balance and gait training, and occupational therapy. Speech and language therapy will also be included according to the patient's needs. Receives: Other: Conventional rehabilitation |
| radial ESWT (rESWT) plus conventional rehabilitation group | Experimental | The rESWT will be applied to the Flexor Carpi Ulnaris (FCU) and Flexor Carpi Radialis (FCR) muscles twice a week for four weeks, totaling eight sessions. The application site will be the midpoint of the most prominent part of each muscle. For each muscle, a 15 mm applicator head will be used to deliver 2000 impulses at a frequency of 5 Hz and an intensity of 60 mJ (1 bar), corresponding to an energy flux density of 0.340 mJ/mm². Additionally, this group will receive physical therapy for 1-2 hours daily, 5 days a week, for 12 weeks. The therapy will include range of motion (ROM) exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-bearing exercises, balance and gait training, and occupational therapy. Speech and language therapy will also be included according to the patient's needs. Receives: Device: Radial Extracorporeal Shock Wave Therapy; Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
The Ashworth Scale assesses the resistance encountered when an evaluator moves a limb through its full range of motion.
According to the Modified Ashworth Scale:
0: No increase in muscle tone.
1: Slight increase in muscle tone, characterized by a catch and release or by minimal resistance at the end of the range of motion.
1+: Slight increase in muscle tone, characterized by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion.
2: More marked increase in muscle tone throughout most of the range of motion, but the affected part(s) can be moved easily.
3: Considerable increase in muscle tone; passive movement is difficult.
4: Affected part(s) are rigid in flexion or extension.
Measured: Baseline, 4th week, 8th week and 12th week after treatment.
Secondary outcomes (5)
Wrist range of motion
During the measurement, the goniometer is aligned with the joint's axis of rotation to determine the maximum angle during passive movement. It is crucial that the limb is moved slowly and carefully to avoid eliciting resistance from the patient's spastic muscles. A slow, controlled movement minimizes spasticity, thereby ensuring a more accurate measurement.Wrist passive range of motion will be measured.
Measured: Baseline 4th week 8th week and 12th week after treatment.
Modified Barthel Index
The Barthel Index (BI) consists of 10 items related to mobility and activities of daily living (ADL), and it assesses activities such as feeding, transfer from wheelchair to bed and back, personal grooming, bathing, walking, ascending and descending stairs, dressing, and bladder and bowel continence.
The Modified Barthel Index (MBI) is a revision of the original Barthel Index (BI) and uses the same 10 items. The main difference between these two measures is that the MBI consistently classifies patient performance into five scoring levels: unable to perform the task, attempts the task but is unsafe, moderate assistance required, minimal assistance required, and fully independent. The total score of the MBI also ranges from 0 to 100, with higher scores indicating greater independence in ADL.
Measured: Baseline, 4th week, 8th week and 12th week after treatment.
The Fugl-Meyer Upper Extremity Scale
The Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) is designed to quantitatively evaluate the motor function of stroke patients and includes tests for upper extremity motor and sensory function. The FMA-UE is used to assess upper extremity motor impairment and contains 33 items scored on a scale from 0 to 2 (0 = cannot perform, 1 = performs partially, and 2 = performs fully), with a total score range of 0-66. The FMA has been reported to have high reliability for testing motor performance in post-stroke patients.
Measured: Baseline, 4th week, 8th week and 12th week after treatment.
Modified Heckmatt Scale
he Modified Heckmatt Scale is a method that uses ultrasonography to reliably evaluate echogenic changes in a spastic muscle, thereby indicating the level of fibrotic change. The Modified Heckmatt Scale was developed to achieve greater sensitivity between grades compared to the original Heckmatt Scale, particularly for muscles with mildly to moderately increased echo intensity (Grades 2 and 3).
Grade 1: Normal echogenicity, distinct from the bone echo, is observed in over 90% of the muscle.
Grade 2: There is increased muscle echogenicity in 10-50% of the tissue, but a distinct bone echo and areas of normal muscle echo are still present.
Grade 3: A marked increase in muscle echogenicity is seen in 50% to 90% of the tissue, with reduced differentiation of the bone echo from the muscle.
Grade 4: Very strong muscle echogenicity is observed in >90% of the tissue, with a near-complete loss of the distinct bone echo from the muscle.
Measured: Baseline, 4th week, 8th week and 12th week after treatment.
Sonoelastographic strain index
Quantitative elastography analysis will be used to measure stiffness. As a software feature of the ultrasound system, quantitative elastography analysis numerically measures the color distribution in a selected area across single or multiple frames and calculates an elasticity index for the measured area.
The elasticity index is a value between 0.0 and 6.0, generated by the reflected color distribution within the selected region. A higher value signifies greater stiffness, which is predominantly represented by the color blue on the screen. While the elasticity index is calculated separately for the reference area and the muscle, the system automatically calculates the strain ratio as muscle/reference area.
Measured: Baseline, 4th week, 8th week and 12th week after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start5 Sep 2025
- Primary completion20 Apr 2026
- Study completion20 Dec 2026 (estimated)
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.
- More trials run by Pamukkale UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Gunes Akinci, Pamukkale University
- Investigators
- Meltem Güneş Akıncı, Assistant professor, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119801
- Sponsor's protocol ID
- PamukkaleU.ftr-MGAkıncı-001
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07119801
- Acronym / sponsor ID
- PamukkaleU.ftr-MGAkıncı-001
- Keywords
- spastic hemiplegia, extracorporeal shockwave therapy, spasticity of the wrist flexors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 13 Aug 2025 (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 research evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) for treating spasticity in the wrist flexor muscles (flexor carpi ulnaris - FCU and flexor carpi radialis - FCR) of chronic stroke patients.
Spasticity, a common complication after a stroke, causes muscle stiffness, pain, and functional limitation, leading to increased healthcare costs and a lower quality of life. Current treatments like medication and injections have significant drawbacks, such as side effects and high costs, creating a need for new, non-invasive, and effective methods.
The study highlights that traditional methods for assessing spasticity, like the Modified Ashworth Scale (MAS), are subjective. It proposes using objective, non-invasive ultrasound techniques-specifically strain elastography (to measure muscle stiffness) and echogenicity (to assess muscle tissue quality)-for a more reliable evaluation.
The primary goal of this research is to be the first to investigate the short- and long-term effects of ESWT on the FCR and FCU muscles using these objective ultrasound measures alongside traditional clinical scales. The findings are expected to help standardize ESWT treatment protocols and promote the use of objective ultrasound data for the management and follow-up of post-stroke spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Other: Conventional rehabilitationThis group will receive physical therapy for 1-2 hours daily, 5 days a week, for 12 weeks. The therapy will include range of motion (ROM) exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-bearing exercises, balance and gait training, and occupational therapy. Speech and language therapy will also be included according to the patient's needs. |
| radial ESWT (rESWT) plus conventional rehabilitation group | Experimental | Device: Radial Extracorporeal Shock Wave Therapy, Other: Conventional rehabilitationThe rESWT will be applied to the Flexor Carpi Ulnaris (FCU) and Flexor Carpi Radialis (FCR) muscles twice a week for four weeks, totaling eight sessions. The application site will be the midpoint of the most prominent part of each muscle. For each muscle, a 15 mm applicator head will be used to deliver 2000 impulses at a frequency of 5 Hz and an intensity of 60 mJ (1 bar), corresponding to an energy flux density of 0.340 mJ/mm². Additionally, this group will receive physical therapy for 1-2 hours daily, 5 days a week, for 12 weeks. The therapy will include range of motion (ROM) exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-bearing exercises, balance and gait training, and occupational therapy. Speech and language therapy will also be included according to the patient's needs. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 35 and 65 years.
- First-ever stroke episode confirmed by MRI and/or CT scan.
- Clinical diagnosis of hemiplegia.
- More than 6 months post-stroke.
- A Modified Ashworth Scale (MAS) score between 1 and 3 for wrist flexor spasticity.
Key exclusion criteria (9 listed)
- History of more than one stroke episode
- Stroke onset more than ten years ago
- Stroke onset less than 6 months ago
- Age over 65 (to limit the effects of aging on muscle structure)
- Contraindications for ESWT (e.g., cancer, local tumor or active infection in the treatment area, pregnancy, coagulation disorders, pacemaker or other electronic/metallic implants)
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 TherapyrESWT will be administered to the FCU and FCR muscles two days per week over a period of four weeks (8 sessions in total). The point of application will be selected as the center of the muscle belly for both the FCU and FCR. Each muscle will receive 2000 shocks using a 15 mm applicator tip at a frequency of 5 Hz. The treatment will be conducted at an intensity of 60 mJ (1 bar), with an energy flux density of 0.340 mJ/mm². | Device | radial ESWT (rESWT) plus conventional rehabilitation group |
| Conventional rehabilitationConventional rehabilitation will be administered for 1-2 hours daily, 5 days a week, for 12 weeks. It will include range of motion exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight shifting, balance, gait training, occupational therapy, and speech-language therapy according to the patient's needs. | Other | Conventional group, radial ESWT (rESWT) plus conventional rehabilitation group |
Primary outcome
Modified Ashworth Scale
Time frame: Baseline, 4th week, 8th week and 12th week after treatment.
The Ashworth Scale assesses the resistance encountered when an evaluator moves a limb through its full range of motion. According to the Modified Ashworth Scale: 0: No increase in muscle tone. 1: Slight increase in muscle tone, characterized by a catch and release or by minimal resistance at the end of the range of motion. 1+: Slight increase in muscle tone, characterized by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion. 2: More marked increase in muscle tone throughout most of the range of motion, but the affected part(s) can be moved easily. 3: Considerable increase in muscle tone; passive movement is difficult. 4: Affected part(s) are rigid in flexion or extension.
5 secondary outcomes
Wrist range of motion
Time frame: Baseline 4th week 8th week and 12th week after treatment.
Modified Barthel Index
Time frame: Baseline, 4th week, 8th week and 12th week after treatment.
The Fugl-Meyer Upper Extremity Scale
Time frame: Baseline, 4th week, 8th week and 12th week after treatment.
Modified Heckmatt Scale
Time frame: Baseline, 4th week, 8th week and 12th week after treatment.
Sonoelastographic strain index
Time frame: Baseline, 4th week, 8th week and 12th week after 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 25 Aug 2026.
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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.
Meltem Güneş Akıncı, Assistant professor study director
Pamukkale University
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 and Conventional rehabilitation in people with Stroke and Spastic Hemiplegia, run by Pamukkale University 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 9 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 25 Aug 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?
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 Meltem Güneş Akıncı, Assistant professor (+905375145590, meltem_aytekin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: Baseline, 4th week, 8th week and 12th week after 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 25 Aug 2026.