Extracorporeal Shock Wave Therapy in Botulinum Toxin-Treated Patients With Post-Stroke Ankle Plantar Flexor Spasticity

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

Overview

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.

Interventions

• Device 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).
• Other Conventional Physical Therapy and Rehabilitation
  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.

Primary outcome measures

• 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)]

Secondary outcome measures (12)

• 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)]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.
• Pregnancy.
• Presence of neuromuscular junction disease or motor neuron disease.
• Known allergy or hypersensitivity to Botulinum Toxin Type A.
• Current use of antibiotics.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitati — Denizli

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. PMID 30843498
• 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
• 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. PMID 26971745
• 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. PMID 37824712
• 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. PMID 31710277
• 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. PMID 40673341
• 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. PMID 40481808

Identifiers

NCT: NCT07695038 · E10189609

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗