StrokeNCT07695038
Extracorporeal Shock Wave Therapy in Botulinum Toxin-Treated Patients With Post-Stroke Ankle Plantar Flexor Spasticity
A study testing Radial Extracorporeal Shock Wave Therapy (rESWT) and Conventional Physical Therapy and Rehabilitation in people with Stroke and Post-stroke Spasticity of the Lower Limb, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if radial Extracorporeal Shock Wave Therapy (rESWT) is effective in reducing ankle plantar flexor spasticity and improving walking functions in stroke patients who have already received Botulinum Toxin type A (BoNT-A) injections. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke, Post-stroke Spasticity of the Lower Limb, Post-Stroke Spasticity
- What is being tested?
- Radial Extracorporeal Shock Wave Therapy (rESWT) and Conventional Physical Therapy and Rehabilitation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2026to 20 Aug 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
- Diagnosis of stroke according to the World Health Organization (WHO) (1989) definition.
- Stroke diagnosis confirmed by magnetic resonance imaging (MRI).
- Patients aged between 18 and 65 years.
- Clinically stable condition after stroke.
- Patients who have undergone routine Botulinum Toxin Type A (BoNT-A) injection to the gastrocnemius muscle.
- Presence of ankle plantar flexor spasticity with a Modified Ashworth Scale (MAS) score of greater than or equal to 1 (MAS ≥ 1).
Who cannot join
- Presence of fixed contracture at the ankle joint.
- History of prior antispastic surgical procedures.
- Changes in antispastic medication dosage or type within the last 6 months.
- Active infection or malignancy at the application site.
- Presence of a cardiac pacemaker.
- Bleeding disorders or advanced vascular disease.
Show all 10Show fewer
- Pregnancy.
- Presence of neuromuscular junction disease or motor neuron disease.
- Known allergy or hypersensitivity to Botulinum Toxin Type A.
- Current use of antibiotics.
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
Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Denizli, Denizli, 20160
Meltem G Akıncı, MD, Assistant Professor, +90 258 296 16 04, meltem_aytekin@hotmail.com
About this study
Official title: Effectiveness of Extracorporeal Shock Wave Therapy as an Adjunct to Botulinum Toxin Injection in Patients With Post-Stroke Ankle Plantar Flexor Spasticity: A Randomized Controlled Trial
The goal of this clinical trial is to learn if radial Extracorporeal Shock Wave Therapy (rESWT) is effective in reducing ankle plantar flexor spasticity and improving walking functions in stroke patients who have already received Botulinum Toxin type A (BoNT-A) injections. The main questions it aims to answer are:
- Does adding rESWT to standard physical therapy significantly lower muscle spasticity in patients who have received BoNT-A, compared to receiving physical therapy alone after the injection?
- Does combining rESWT with BoNT-A injection improve functional walking parameters (such as gait speed, cadence, and step length) and daily life independence more than the BoNT-A and physical therapy combination alone?
- Can rESWT induce additional structural and flexibility improvements in the BoNT-A injected gastrocnemius muscle, as measured objectively by ultrasound imaging and strain elastography?
Read more
Researchers will compare a group of participants receiving both rESWT and conventional physical therapy (Group 1) to a comparison group receiving only conventional physical therapy (Group 2) to see if rESWT provides additional clinical benefits. All participants in both groups will have already undergone routine BoNT-A injections one week prior to starting the study treatments.
Participants will:
- Undergo a 3-week conventional physical therapy and rehabilitation program, consisting of 2 to 3 hours of therapy per day, 5 days a week.
- Receive 3 weekly sessions of rESWT (2000 pulses per session applied to the calf muscles) if they are randomized into the rESWT group.
- Attend clinical evaluation visits and objective assessment sessions-including high-tech computerized gait analysis and specialized musculoskeletal ultrasound imaging-before the treatment, at the end of the 3rd week, and at a 12-week follow-up.
- Conditions
- Stroke, Post-stroke Spasticity of the Lower Limb, Post-Stroke Spasticity, Spasticity of the Plantar Flexors, Spasticity, Post-Stroke
- Being tested
- Radial Extracorporeal Shock Wave Therapy (rESWT), Conventional Physical Therapy and Rehabilitation
- 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.
Radial Extracorporeal Shock Wave Therapy (rESWT)Device
Applied 1 week after the routine Botulinum Toxin Type A (BoNT-A) injection. Patients receive 3 sessions (once a week for 3 weeks) of rESWT to the medial and lateral heads of the gastrocnemius muscle in the prone position with knee in full extension and ankle in neutral. Dose parameters: 2000 pulses per session, 5 Hz frequency, and 60 mJ (1 bar) energy level using a 15 mm transmitter head (calculated energy flux density: 0.340 mJ/mm²).
Conventional Physical Therapy and RehabilitationOther
A 3-week comprehensive rehabilitation program performed 2-3 hours per day, 5 days a week. The program includes passive/active range of motion exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-shifting, balance training, gait training, occupational therapy, and speech therapy based on individual patient needs.
| Study group | Role | What they receive |
|---|---|---|
| rESWT + Physical Therapy | Experimental | Patients receive routine BoNT-A injection, followed by 3 weekly sessions of radial Extracorporeal Shock Wave Therapy (rESWT) and a 3-week conventional physical therapy program. Receives: Device: Radial Extracorporeal Shock Wave Therapy (rESWT); Other: Conventional Physical Therapy and Rehabilitation |
| Physical Therapy Alone | Active comparator | Patients receive routine BoNT-A injection, followed only by a 3-week conventional physical therapy program without rESWT. Receives: Other: Conventional Physical Therapy and Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Muscle Spasticity Grade using the Modified Ashworth Scale (MAS)
The MAS is a clinical scale used to assess resistance to passive movement in a joint affected by spasticity. Scores range from 0 to 4 (with an additional 1+ score), where 0 indicates no increase in muscle tone and 4 indicates the affected part is rigid in flexion or extension. Higher scores represent greater muscle spasticity.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Secondary outcomes (13)
Change from Baseline in Passive Ankle Dorsiflexion Range of Motion (ROM)
Measured in degrees using a standard universal goniometer. The measurement will be taken with the patient in the supine position and the knee fully extended to better demonstrate the gastrocnemius muscle restriction. Higher degrees indicate better range of motion.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Activities of Daily Living Using the Modified Barthel Index (MBI)
The MBI is used to assess the patient's level of independence in 10 activities of daily living. Total scores range from 0 to 100, where higher scores reflect greater independence.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Lower Extremity Motor Function Using the Fugl-Meyer Assessment Lower Extremity (FMA-LE)
The FMA-LE is an index designed to assess sensorimotor impairment post-stroke. The lower extremity subscale consists of items scoring reflexes, voluntary movements, and coordination, with total scores ranging from 0 to 34. Higher scores indicate better motor function.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Muscle Fibrotic Alterations Using the Modified Heckmatt Scale
visual ultrasound grading scale used to evaluate echogenic changes and fibrotic levels in the spastic muscle tissue. Scores range from Grade 1 (normal muscle echogenicity) to Grade 4 (very strong muscle echogenicity with complete loss of bone echo). Higher grades indicate increased fibrotic changes and muscle echo intensity.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Muscle Stiffness Using Sonoelastography Strain Index (SI)
Musculoskeletal strain ultrasound elastography will be used to analyze tissue deformation and calculate the elasticity index. Scores range from 0.0 to 6.0, where higher index values represent greater muscle tissue stiffness.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Muscle Stiffness Using Sonoelastography Strain Ratio (SR)
The strain ratio is calculated automatically by the ultrasound software as the ratio of tissue deformation between the target spastic muscle area and a reference subcutaneous fat area (muscle/reference area). A higher strain ratio represents greater muscle tissue stiffness and loss of elasticity.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Walking Velocity Using Rehawalk Computerized Analysis
Objective spatiotemporal variable captured via the Rehawalk Zebris FDM-T pressure-sensor matrix. This outcome will specifically measure overall walking velocity during steady-state treadmill walking. The data will be evaluated and reported in kilometers per hour (km/h). Higher values indicate an improvement in walking speed.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Cadence Using Rehawalk Computerized Analysis
Objective spatiotemporal variable evaluating the step frequency during treadmill walking. This outcome will record the total number of steps taken per minute. The data will be evaluated and reported in steps per minute (steps/min). Higher cadence values reflect a closer-to-normal stepping frequency.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Step Width Using Rehawalk Computerized Analysis
Objective spatial gait parameter measured via the Rehawalk Zebris FDM-T pressure-sensor matrix. This outcome evaluates the lateral distance between both feet during steady-state treadmill walking. The data will be recorded and reported in centimeters (cm).
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Single-Support Phase Duration Using Rehawalk Computerized Analysis
Objective temporal gait parameter reflecting the duration of the gait cycle during which only one foot is in contact with the treadmill surface. Measurements will be recorded for both the affected and unaffected lower limbs. The data will be reported in seconds (sec) or as a percentage (%) of the total gait cycle.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Double-Support Phase Duration Using Rehawalk Computerized Analysis
Objective temporal gait parameter reflecting the duration of the gait cycle during which both feet are simultaneously in contact with the treadmill surface. This parameter is crucial for assessing dynamic stability post-stroke. The data will be reported in seconds (sec) or as a percentage (%) of the total gait cycle.
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Stride Length Using Rehawalk Computerized Analysis
Objective spatial gait parameter measuring the linear distance between two successive heel strikes of the same foot (double step length). This will be evaluated to track improvements in step efficiency and limb advancement. The data will be recorded and reported in centimeters (cm).
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Temporal Gait Symmetry Index (TGSI) Using Rehawalk Computerized Analysis
An index calculated from the temporal parameters captured by the sensor matrix to evaluate hemiparetic gait asymmetry. The specific mathematical formula used is: (Single support duration of the patient's unaffected side / Single support duration of the affected side). A value closer to 1.0 represents a more symmetrical, balanced, and normal gait pattern. (Unit of measure: Score/Ratio).
Measured: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695038
- Sponsor's protocol ID
- E10189609
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the future publication of this study will be made available upon reasonable request for academic and research purposes.
Publications
Duan H, Chen X, Li H, Liu X, Liu N, Li Z. Efficacy of botulinum toxin type a combined with low-frequency extracorporeal shock wave in the treatment of post-stroke triceps spasticity of the calf muscle. Chin J Phys Med Rehabil. (2020) 42:992-4. doi: 10.3760/cma.j.issn.0254-1424.2020.11.007
Megna M, Marvulli R, Fari G, Gallo G, Dicuonzo F, Fiore P, Ianieri G. Pain and Muscles Properties Modifications After Botulinum Toxin Type A (BTX-A) and Radial Extracorporeal Shock Wave (rESWT) Combined Treatment. Endocr Metab Immune Disord Drug Targets. 2019;19(8):1127-1133. doi: 10.2174/1871530319666190306101322.
PubMed 30843498Wang H, Zhao C, Yuan H, Liu W, Yuan H, Hui N, et al. The efficacy of botulinum toxin type a combined with shockwave therapy on the spastic state of the lower limbs after stroke. Chin J Rehabil Med. (2017) 32:773-8. doi: 10.3969/j.issn.1001-1242.2017.07.008
Radinmehr H, Nakhostin Ansari N, Naghdi S, Olyaei G, Tabatabaei A. Effects of one session radial extracorporeal shockwave therapy on post-stroke plantarflexor spasticity: a single-blind clinical trial. Disabil Rehabil. 2017 Mar;39(5):483-490. doi: 10.3109/09638288.2016.1148785. Epub 2016 Mar 13.
PubMed 26971745Afzal B, Noor R, Mumtaz N, Bashir MS. Effects of extracorporeal shock wave therapy on spasticity, walking and quality of life in poststroke lower limb spasticity: a systematic review and meta-analysis. Int J Neurosci. 2024 Dec;134(12):1503-1517. doi: 10.1080/00207454.2023.2271164. Epub 2023 Nov 14.
PubMed 37824712Cabanas-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 31710277Talay Calis H, Cansin F, Kocer E, Ulku Demir FG. Evaluation of the efficacy of extracorporeal shock wave therapy following botulinum toxin type a injection on post-stroke ankle plantar flexor spasticity. Top Stroke Rehabil. 2026 Mar;33(2):175-183. doi: 10.1080/10749357.2025.2532424. Epub 2025 Jul 17.
PubMed 40673341Peng HH, Sung MJ, Lee YH, Huang SW, Lin LC. Effects of extracorporeal shock wave therapy on motor function in patients with cerebral palsy: a systematic review and meta-analysis. Disabil Rehabil. 2025 Dec;47(25):6526-6535. doi: 10.1080/09638288.2025.2514261. Epub 2025 Jun 7.
PubMed 40481808Du YN, Li Y, Zhang TY, Jiang N, Wei Y, Cheng SH, Li H, Duan HY. Efficacy of botulinum toxin A combined with extracorporeal shockwave therapy in post-stroke spasticity: a systematic review. Front Neurol. 2024 Mar 15;15:1342545. doi: 10.3389/fneur.2024.1342545. eCollection 2024.
PubMed 38560731Mihai EE, Dumitru L, Mihai IV, Berteanu M. Long-Term Efficacy of Extracorporeal Shock Wave Therapy on Lower Limb Post-Stroke Spasticity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Dec 29;10(1):86. doi: 10.3390/jcm10010086.
PubMed 33383655
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extracorporeal Shock Wave Therapy as an Adjunct to Botulinum Toxin Injection in Patients With Post-Stroke Ankle Plantar Flexor Spasticity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07695038
- Acronym / sponsor ID
- E10189609
- Conditions
- Stroke, Post-stroke Spasticity of the Lower Limb, Post-Stroke Spasticity, Spasticity of the Plantar Flexors, Spasticity, Post-Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 10 Jul 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.
The goal of this clinical trial is to learn if radial Extracorporeal Shock Wave Therapy (rESWT) is effective in reducing ankle plantar flexor spasticity and improving walking functions in stroke patients who have already received Botulinum Toxin type A (BoNT-A) injections. The main questions it aims to answer are:
- Does adding rESWT to standard physical therapy significantly lower muscle spasticity in patients who have received BoNT-A, compared to receiving physical therapy alone after the injection?
- Does combining rESWT with BoNT-A injection improve functional walking parameters (such as gait speed, cadence, and step length) and daily life independence more than the BoNT-A and physical therapy combination alone?
- Can rESWT induce additional structural and flexibility improvements in the BoNT-A injected gastrocnemius muscle, as measured objectively by ultrasound imaging and strain elastography?
Researchers will compare a group of participants receiving both rESWT and conventional physical therapy (Group 1) to a comparison group receiving only conventional physical therapy (Group 2) to see if rESWT provides additional clinical benefits. All participants in both groups will have already undergone routine BoNT-A injections one week prior to starting the study treatments.
Participants will:
- Undergo a 3-week conventional physical therapy and rehabilitation program, consisting of 2 to 3 hours of therapy per day, 5 days a week.
- Receive 3 weekly sessions of rESWT (2000 pulses per session applied to the calf muscles) if they are randomized into the rESWT group.
- Attend clinical evaluation visits and objective assessment sessions-including high-tech computerized gait analysis and specialized musculoskeletal ultrasound imaging-before the treatment, at the end of the 3rd week, and at a 12-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rESWT + Physical Therapy | Experimental | Device: Radial Extracorporeal Shock Wave Therapy (rESWT), Other: Conventional Physical Therapy and RehabilitationPatients receive routine BoNT-A injection, followed by 3 weekly sessions of radial Extracorporeal Shock Wave Therapy (rESWT) and a 3-week conventional physical therapy program. |
| Physical Therapy Alone | Active comparator | Other: Conventional Physical Therapy and RehabilitationPatients receive routine BoNT-A injection, followed only by a 3-week conventional physical therapy program without rESWT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stroke according to the World Health Organization (WHO) (1989) definition.
- Stroke diagnosis confirmed by magnetic resonance imaging (MRI).
- Patients aged between 18 and 65 years.
- Clinically stable condition after stroke.
- Patients who have undergone routine Botulinum Toxin Type A (BoNT-A) injection to the gastrocnemius muscle.
Key exclusion criteria (10 listed)
- Presence of fixed contracture at the ankle joint.
- History of prior antispastic surgical procedures.
- Changes in antispastic medication dosage or type within the last 6 months.
- Active infection or malignancy at the application site.
- Presence of a cardiac pacemaker.
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)Applied 1 week after the routine Botulinum Toxin Type A (BoNT-A) injection. Patients receive 3 sessions (once a week for 3 weeks) of rESWT to the medial and lateral heads of the gastrocnemius muscle in the prone position with knee in full extension and ankle in neutral. Dose parameters: 2000 pulses per session, 5 Hz frequency, and 60 mJ (1 bar) energy level using a 15 mm transmitter head (calculated energy flux density: 0.340 mJ/mm²). | Device | rESWT + Physical Therapy |
| Conventional Physical Therapy and RehabilitationA 3-week comprehensive rehabilitation program performed 2-3 hours per day, 5 days a week. The program includes passive/active range of motion exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-shifting, balance training, gait training, occupational therapy, and speech therapy based on individual patient needs. | Other | Physical Therapy Alone, rESWT + Physical Therapy |
Primary outcome
Change from Baseline in Muscle Spasticity Grade using the Modified Ashworth Scale (MAS)
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
The MAS is a clinical scale used to assess resistance to passive movement in a joint affected by spasticity. Scores range from 0 to 4 (with an additional 1+ score), where 0 indicates no increase in muscle tone and 4 indicates the affected part is rigid in flexion or extension. Higher scores represent greater muscle spasticity.
13 secondary outcomes
Change from Baseline in Passive Ankle Dorsiflexion Range of Motion (ROM)
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Activities of Daily Living Using the Modified Barthel Index (MBI)
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Lower Extremity Motor Function Using the Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Muscle Fibrotic Alterations Using the Modified Heckmatt Scale
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Muscle Stiffness Using Sonoelastography Strain Index (SI)
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Muscle Stiffness Using Sonoelastography Strain Ratio (SR)
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Walking Velocity Using Rehawalk Computerized Analysis
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Cadence Using Rehawalk Computerized Analysis
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Step Width Using Rehawalk Computerized Analysis
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Single-Support Phase Duration Using Rehawalk Computerized Analysis
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Double-Support Phase Duration Using Rehawalk Computerized Analysis
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Stride Length Using Rehawalk Computerized Analysis
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Temporal Gait Symmetry Index (TGSI) Using Rehawalk Computerized Analysis
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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 10 Jul 2026.
- BackgroundDuan H, Chen X, Li H, Liu X, Liu N, Li Z. Efficacy of botulinum toxin type a combined with low-frequency extracorporeal shock wave in the treatment of post-stroke triceps spasticity of the calf muscle. Chin J Phys Med Rehabil. (2020) 42:992-4. doi: 10.3760/cma.j.issn.0254-1424.2020.11.007
- Background: PubMed 30843498Megna M, Marvulli R, Fari G, Gallo G, Dicuonzo F, Fiore P, Ianieri G. Pain and Muscles Properties Modifications After Botulinum Toxin Type A (BTX-A) and Radial Extracorporeal Shock Wave (rESWT) Combined Treatment. Endocr Metab Immune Disord Drug Targets. 2019;19(8):1127-1133. doi: 10.2174/1871530319666190306101322.
- BackgroundWang H, Zhao C, Yuan H, Liu W, Yuan H, Hui N, et al. The efficacy of botulinum toxin type a combined with shockwave therapy on the spastic state of the lower limbs after stroke. Chin J Rehabil Med. (2017) 32:773-8. doi: 10.3969/j.issn.1001-1242.2017.07.008
- Background: PubMed 26971745Radinmehr H, Nakhostin Ansari N, Naghdi S, Olyaei G, Tabatabaei A. Effects of one session radial extracorporeal shockwave therapy on post-stroke plantarflexor spasticity: a single-blind clinical trial. Disabil Rehabil. 2017 Mar;39(5):483-490. doi: 10.3109/09638288.2016.1148785. Epub 2016 Mar 13.
- Background: PubMed 37824712Afzal B, Noor R, Mumtaz N, Bashir MS. Effects of extracorporeal shock wave therapy on spasticity, walking and quality of life in poststroke lower limb spasticity: a systematic review and meta-analysis. Int J Neurosci. 2024 Dec;134(12):1503-1517. doi: 10.1080/00207454.2023.2271164. Epub 2023 Nov 14.
- Background: 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.
- Background: PubMed 40673341Talay Calis H, Cansin F, Kocer E, Ulku Demir FG. Evaluation of the efficacy of extracorporeal shock wave therapy following botulinum toxin type a injection on post-stroke ankle plantar flexor spasticity. Top Stroke Rehabil. 2026 Mar;33(2):175-183. doi: 10.1080/10749357.2025.2532424. Epub 2025 Jul 17.
- Background: PubMed 40481808Peng HH, Sung MJ, Lee YH, Huang SW, Lin LC. Effects of extracorporeal shock wave therapy on motor function in patients with cerebral palsy: a systematic review and meta-analysis. Disabil Rehabil. 2025 Dec;47(25):6526-6535. doi: 10.1080/09638288.2025.2514261. Epub 2025 Jun 7.
- Background: PubMed 38560731Du YN, Li Y, Zhang TY, Jiang N, Wei Y, Cheng SH, Li H, Duan HY. Efficacy of botulinum toxin A combined with extracorporeal shockwave therapy in post-stroke spasticity: a systematic review. Front Neurol. 2024 Mar 15;15:1342545. doi: 10.3389/fneur.2024.1342545. eCollection 2024.
- Background: PubMed 33383655Mihai EE, Dumitru L, Mihai IV, Berteanu M. Long-Term Efficacy of Extracorporeal Shock Wave Therapy on Lower Limb Post-Stroke Spasticity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Dec 29;10(1):86. doi: 10.3390/jcm10010086.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the future publication of this study will be made available upon reasonable request for academic and research purposes.
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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.
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) and Conventional Physical Therapy and Rehabilitation in people with Stroke and Post-stroke Spasticity of the Lower Limb, 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 10 Jul 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 G Akıncı, MD, Assistant Professor (+90 258 296 16 04, meltem_aytekin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Muscle Spasticity Grade using the Modified Ashworth Scale (MAS) (time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)). 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 NCT07695038, which also lists 10 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 10 Jul 2026.