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

4 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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).
Altro: 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.
Comparatore attivo: Physical Therapy Alone
Patients receive routine BoNT-A injection, followed only by a 3-week conventional physical therapy program without rESWT.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Muscle Spasticity Grade using the Modified Ashworth Scale (MAS)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Passive Ankle Dorsiflexion Range of Motion (ROM)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pamukkale University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 luglio 2026

Completamento primario (Stimato)

20 luglio 2027

Completamento dello studio (Stimato)

20 agosto 2027

Date di iscrizione allo studio

Primo inviato

23 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 luglio 2026

Primo Inserito (Effettivo)

10 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • E10189609

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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