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

4. července 2026 aktualizováno: Meltem Gunes Akinci, Pamukkale University

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?

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

32

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Turecko (Türkiye)
    • Denizli
      • Denizli, Denizli, Turecko (Türkiye), 20160
        • Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: rESWT + Physical Therapy
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.
Přístroj: 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).
Jiný: 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.
Aktivní komparátor: Physical Therapy Alone
Patients receive routine BoNT-A injection, followed only by a 3-week conventional physical therapy program without rESWT.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in Muscle Spasticity Grade using the Modified Ashworth Scale (MAS)
Časové okno: 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.
Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in Passive Ankle Dorsiflexion Range of Motion (ROM)
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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)
Change from Baseline in Activities of Daily Living Using the Modified Barthel Index (MBI)
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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)
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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)
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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)
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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
Časové okno: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pamukkale University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

20. července 2026

Primární dokončení (Odhadovaný)

20. července 2027

Dokončení studie (Odhadovaný)

20. srpna 2027

Termíny zápisu do studia

První předloženo

23. června 2026

První předloženo, které splnilo kritéria kontroly kvality

4. července 2026

První zveřejněno (Aktuální)

10. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. července 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • E10189609

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

Data will be available beginning 6 months and ending 3 years following article publication.

Kritéria přístupu pro sdílení IPD

Requests should be directed to the principal investigator via email (meltem_aytekin@hotmail.com). A formal proposal specifying the research objectives must be provided.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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