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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Physical Therapy Alone | Active Comparator | Patients receive routine BoNT-A injection, followed only by a 3-week conventional physical therapy program without rESWT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meltem G Akıncı, MD, Assistant Professor | Contact | +90 258 296 16 04 | meltem_aytekin@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation | Denizli | Denizli | 20160 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 30843498 | Background | 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. | |
| Background | Wang 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 | ||
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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.
Data will be available beginning 6 months and ending 3 years following article publication.
Requests should be directed to the principal investigator via email (meltem_aytekin@hotmail.com). A formal proposal specifying the research objectives must be provided.
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|
| Conventional Physical Therapy and Rehabilitation | Other | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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). | 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). | Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up) |
| Background |
| 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. |
| 37824712 | Background | Afzal 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. |
| 31710277 | Background | Cabanas-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. |
| 40673341 | Background | Talay 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. |
| 40481808 | Background | Peng 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. |
| 38560731 | Background | Du 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. |
| 33383655 | Background | Mihai 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. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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