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

NCT07695038 | Not Yet Recruiting

• 1 other identifier: E10189609
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Post-stroke Spasticity of the Lower Limb; Post-Stroke Spasticity; Spasticity of the Plantar Flexors; Spasticity, Post-Stroke

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (13)

• Change from Baseline in Passive Ankle Dorsiflexion Range of Motion (ROM)

  Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)

• Change from Baseline in Activities of Daily Living Using the Modified Barthel Index (MBI)

  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)

  Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)

• Change from Baseline in Muscle Fibrotic Alterations Using the Modified Heckmatt Scale

  Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)

• Change from Baseline in Muscle Stiffness Using Sonoelastography Strain Index (SI)

  Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)

Study Arms (2)

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.

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.

Other: Conventional Physical Therapy and Rehabilitation

Interventions

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).

rESWT + Physical Therapy

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.

Physical Therapy Alone; rESWT + Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Denizli, Denizli, 20160, Turkey (Türkiye)

Location

Related Publications (10)

• 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

  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.

  PMID: 30843498 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

  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.

  PMID: 26971745 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.

  PMID: 37824712 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.

  PMID: 31710277 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.

  PMID: 40673341 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.

  PMID: 40481808 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.

  PMID: 38560731 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.

  PMID: 33383655 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Meltem G Akıncı, MD, Assistant Professor

CONTACT

+90 258 296 16 04; meltem_aytekin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 10, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months and ending 3 years following article publication.
• Access Criteria: Requests should be directed to the principal investigator via email (meltem\ aytekin@hotmail.com). A formal proposal specifying the research objectives must be provided.

Locations

TU (1)