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Efficacia della Diatermia a Onde d'Urto Extracorporea nella Gestione della Funzione dell'Arto Superiore in Pazienti con Ictus.

21 settembre 2026 aggiornato da: Gulf Medical University

Efficacia della Diatermia con Onde d'Urto Extracorporee nella Gestione della Funzione dell'Arto Superiore in Pazienti con Ictus: Studio Controllato Randomizzato.

Stroke is a leading cause of death and disability worldwide. A major complication of stroke is spasticity, marked by increased muscle tone and impaired movement. It affects majority stroke patients and complicates rehabilitation, affecting the upper limb function of survivors.

While traditional treatments like oral medications and botulinum toxin injections offer some relief, they have notable limitations, causing the need for novel, non-invasive approaches. Extracorporeal shock wave therapy (ESWT), which uses acoustic waves for regeneration and neuromodulation, has shown promise in reducing spasticity with minimal side effects, though its precise mechanisms and ideal protocols need further study. Current evidence supports ESWT's efficacy and safety, often matching established treatments, but gaps remain regarding standardized application and long-term functional outcomes, highlighting the need for more robust research.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Stroke is one of the leading causes of mortality and long-term disability, with millions of new cases each year and a large proportion of survivors living with lasting impairments in movement and function. After a stroke, damage to the motor areas and descending pathways of the brain frequently leads to spasticity, a condition in which muscles become abnormally tight and resist passive stretch; this increase in muscle tone is velocity-dependent and often accompanied by weakness and loss of selective control. Spasticity develops in a substantial proportion of stroke survivors and is especially disabling when it involves the upper limb, where it interferes with reaching, grasping, releasing, and the performance of essential activities of daily living such as dressing, feeding, and personal care.

Upper limb involvement is particularly common because most strokes affect the middle cerebral artery (MCA) territory, which supplies key regions of the motor cortex and internal capsule responsible for control of the face and arm more than the leg. As a result, many patients present with the characteristic pattern of flexor spasticity in the shoulder, elbow, wrist, and fingers, while the lower limb may show relatively better recovery or a different pattern of impairment. Recovery of upper limb function is also typically slower and less complete than that of the lower limb: walking often returns earlier, whereas fine hand and arm movements require more complex cortical processing and richer sensorimotor integration, which are more vulnerable to damage and harder to reorganize. This slower recovery reflects, in part, the lower effective neuroplasticity or more limited spontaneous re-organization in upper limb networks after stroke, meaning that more intensive, targeted, and often multimodal interventions are needed to restore arm and hand function.

Because of these factors, the upper limb frequently remains a limitation for independence even when a patient can walk, and persistent spasticity in the arm can further block functional gains by causing abnormal postures, contractures, and pain. Traditional approaches to spasticity management; such as oral antispastic medications and botulinum toxin injections can reduce muscle tone, but they often provide only temporary relief, may have systemic or local side effects, and do not always translate into meaningful functional improvements. These limitations have driven interest in innovative, non-invasive options that can modulate muscle tone and support neuroplasticity while fitting into comprehensive rehabilitation programs.

Extracorporeal shock wave therapy (ESWT) is one such emerging modality as it delivers controlled acoustic waves to targeted muscles and soft tissues and is thought to act through a combination of mechanical, vascular, and neuromodulator mechanisms. Experimental and clinical studies suggest that ESWT may reduce spasticity by altering reflex excitability, influencing neuromuscular junction function, and promoting tissue regeneration and remodeling, with reported side effects generally mild and transient. Early and mid-term clinical evidence indicates that ESWT can safely decrease spasticity and, in some trials, achieve functional gains comparable to more established treatments, but the exact mechanisms, optimal parameters (energy, frequency, number of shocks, treatment sites, and session frequency), and long-term functional impact are not yet fully defined.

This study focuses on the upper limb spasticity as it is the region where disability is often greatest, recovery is slowest, and current options are imperfect. By targeting key flexor muscle groups of the affected upper limb with ESWT, the aim is to reduce pathological muscle overactivity and spasticity, thereby creating a more favorable biomechanical and neurophysiological environment for active training and functional use. The study plan hypothesizes that systematically applied ESWT, integrated with structured rehabilitation, can meaningfully improve upper limb function in stroke, addressing a critical unmet need in post-stroke care and contributing evidence toward standardized, parameter-based ESWT protocols.

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

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

Backup dei contatti dello studio

  • Nome: Ramprasad Muthukrishnan, Phd/
  • Numero di telefono: 1551 +971 6 7431333
  • Email: mrp@gmu.ac.ae

Luoghi di studio

    • Ajman Emirate
      • Ajman, Ajman Emirate, Emirati Arabi Uniti
        • Reclutamento
        • Gulf Medical University
        • Contatto:
          • Dr. Ramprasad Muthukrishnan, Ph.D
          • Numero di telefono: 1551 971-555917250
          • Email: mrp@gmu.ac.ae
        • Contatto:
          • Sateesh Durairaj, PhD
          • Numero di telefono: 971-551808474

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

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion criteria:

  1. Diagnosed as 1st stroke incidence 6 months back
  2. Both male and female
  3. Age 25 to 65 years
  4. the ability to follow verbal instructions
  5. Modified Ashworth Scale score 1-4

Exclusion criteria:

  1. Recurrent stroke.
  2. Severe contractures or deformities of upper extremity.
  3. Chronic pain affecting upper extremity function.
  4. malignant tumor, pacemakers, infection

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: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental group

Participants randomized in to experimental group will receive Extra-corporeal Shockwave therapy applied to the spastic upper limb muscles along with conventional upper limb physiotherapy program.

Target muscles: biceps brachii, flexor carpi radialis, pronator teres, wrist and finger flexors.

Protocol: 2000 shocks per muscle per session, energy flux density 0.03 mJ/mm², frequency 8 Hz, pressure ~0.2 MPa (2 bars).(1)

Sustained stretches held for 10 seconds, 3-5 repetitions per muscle group

Active and passive range of motion (ROM) exercises, 10-15 reps

Isometric/ Isotonic exercises for antagonist muscles, 3 sets of 10-15 reps

Task-oriented activities ADLs. Eg: grasping, reaching, manipulation, 20-30 minutes per session

Comparatore fittizio: Control group

Participants randomized in to control group will receive sham Extra-corporeal Shockwave therapy applied to the spastic upper limb muscles along with conventional upper limb physiotherapy program.

Sustained stretches held for 10 seconds, 3-5 repetitions per muscle group

Active and passive range of motion (ROM) exercises, 10-15 reps

Isometric/ Isotonic exercises for antagonist muscles, 3 sets of 10-15 reps

Task-oriented activities ADLs. Eg: grasping, reaching, manipulation, 20-30 minutes per session

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Upper limb function test
Lasso di tempo: Baseline, post intervention (6 week), 1 month followup (10 weeks)

The upper limb function will be evaluated using the Neofect Smart Board test. The test will involve three different kinematic assessment programs: free exploration, point-to-point reaching, and circle-drawing.Data will be recorded as time taken to complete the evaluation (s) then the average of three tasks will serve to denote the upperlimb function. Each assessment program has a time limit of 60 s. (2)

Baseline, post intervention (6 week), 1 month followup (10 weeks)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Electrical activation of muscle
Lasso di tempo: Baseline, post intervention (6 week), 1 month followup (10 weeks)

Muscle activity will be objectively assessed using using the BTS, Electromyography (EMG) system to measure amplitude of root mean square (RMS) (µV).(3) RMS reflects the overall level at rest and during movement.The subject will be asked to be seated comfortably on a chair with his/her arm rested on a table, elbow extension at 110°-120°, and the wrist placed in the neutral position. The subject will be requested four motion patterns spherical grasp, hand opening, tripod pinch , and hook grip. Each movement will be performed 3 times in pair, for accuracy.

During this process six EMG sensors will placed on the six muscles: flexor digitorum superficialis (FDS), flexor digitorum Profundus (FDP), medial head of extensor digitorum (EDM), lateral head of extensor digitorum (EDL), extensor pollicis longus (EPL), and extensor carpi radialis longus (ECR) muscle on the tested side.(3)

Baseline, post intervention (6 week), 1 month followup (10 weeks)
Muscles force generating capacity
Lasso di tempo: Baseline, post intervention (6 week), 1 month followup (10 weeks)

Muscle's highest force-generating capacity during voluntary effort will be recorded with maximum voluntary contraction (MVC) (expressed as %).(3). The subject will be asked to follow the same EMG procedure denoted for recording the overall electrical activity of the muscle. Except in each pair of movement, one movement will be performed at maximum voluntary contraction (MVC) and the other one at comfortable force.

Baseline, post intervention (6 week), 1 month followup (10 weeks)

Collaboratori e investigatori

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

Sponsor

Investigatori

  • Investigatore principale: Sharmila banu Ali, DPT/MPT, Thumbay Physical Therapy and Rehabilitation Hospital

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.

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 (Effettivo)

30 ottobre 2025

Completamento primario (Stimato)

28 febbraio 2027

Completamento dello studio (Stimato)

30 marzo 2027

Date di iscrizione allo studio

Primo inviato

16 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 aprile 2026

Primo Inserito (Effettivo)

9 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • IRB-COHS-FAC-57-Jan-2026

Piano per i dati dei singoli partecipanti (IPD)

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

NO

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 .