- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07520032
Skuteczność diatermii falami uderzeniowymi pozaciałaniowymi w zarządzaniu funkcją kończyny górnej u pacjentów po udarze.
Skuteczność pozaustrojowej diatermii falą uderzeniową w leczeniu pacjentów z udarem z zaburzeniami funkcji kończyny górnej: randomizowane badanie kontrolowane.
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Sharmila banu Ali, DPT
- Numer telefonu: 1906 067031555
- E-mail: sharmieashak@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Ramprasad Muthukrishnan, Phd/
- Numer telefonu: 1551 +971 6 7431333
- E-mail: mrp@gmu.ac.ae
Lokalizacje studiów
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Ajman Emirate
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Ajman, Ajman Emirate, Zjednoczone Emiraty Arabskie
- Rekrutacyjny
- Gulf Medical University
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Kontakt:
- Dr. Ramprasad Muthukrishnan, Ph.D
- Numer telefonu: 1551 971-555917250
- E-mail: mrp@gmu.ac.ae
-
Kontakt:
- Sateesh Durairaj, PhD
- Numer telefonu: 971-551808474
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion criteria:
- Diagnosed as 1st stroke incidence 6 months back
- Both male and female
- Age 25 to 65 years
- the ability to follow verbal instructions
- Modified Ashworth Scale score 1-4
Exclusion criteria:
- Recurrent stroke.
- Severe contractures or deformities of upper extremity.
- Chronic pain affecting upper extremity function.
- malignant tumor, pacemakers, infection
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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 |
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Pozorny komparator: 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 |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Upper limb function test
Ramy czasowe: Baseline, post intervention (6 week), 1 month followup (10 weeks)
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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)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Electrical activation of muscle
Ramy czasowe: 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)
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Muscles force generating capacity
Ramy czasowe: Baseline, post intervention (6 week), 1 month followup (10 weeks)
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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)
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Sharmila banu Ali, DPT/MPT, Thumbay Physical Therapy and Rehabilitation Hospital
Publikacje i pomocne linki
Publikacje ogólne
- Silverman JD, Balbinot G, Masani K, Zariffa J, Eng P. Validity and Reliability of Surface Electromyography Features in Lower Extremity Muscle Contraction in Healthy and Spinal Cord-Injured Participants. Top Spinal Cord Inj Rehabil. 2021 Fall;27(4):14-27. doi: 10.46292/sci20-00001. Epub 2021 Feb 8.
- Park M, Ko MH, Oh SW, Lee JY, Ham Y, Yi H, Choi Y, Ha D, Shin JH. Effects of virtual reality-based planar motion exercises on upper extremity function, range of motion, and health-related quality of life: a multicenter, single-blinded, randomized, controlled pilot study. J Neuroeng Rehabil. 2019 Oct 24;16(1):122. doi: 10.1186/s12984-019-0595-8.
- Duan H, Lian Y, Jing Y, Xing J, Li Z. Research progress in extracorporeal shock wave therapy for upper limb spasticity after stroke. Front Neurol. 2023 Feb 9;14:1121026. doi: 10.3389/fneur.2023.1121026. eCollection 2023.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia naczyniowo-mózgowe
- Choroby mózgu
- Choroby ośrodkowego układu nerwowego
- Choroby Układu Nerwowego
- Choroby naczyniowe
- Choroby układu krążenia
- Uderzenie
- Aktywność motoryczna
- Ruch
- Physiologiczne zjawiska mięśniowo -szkieletowe
- Zjawiska fizjologiczne mięśniowo -szkieletowe i nerwowe
- Lecznictwo
- Techniki i procedury diagnostyczne
- Diagnoza
- Fizjoterapia
- Opieka nad pacjentem
- Terapia ćwiczeń
- Rehabilitacja
- Opieka postpenitencjarna
- Ciągłość opieki nad pacjentem
- Kondycjonowanie fizyczne, człowiek
- Ćwiczenia
- Badanie fizyczne
- Trening oporu
- Zakres ruchu, artykuł stawowy
Inne numery identyfikacyjne badania
- IRB-COHS-FAC-57-Jan-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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