Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity

Официальное название

Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity: A Randomized Controlled Trial

Обзор

This research evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) for treating spasticity in the wrist flexor muscles (flexor carpi ulnaris - FCU and flexor carpi radialis - FCR) of chronic stroke patients. Spasticity, a common complication after a stroke, causes muscle stiffness, pain, and functional limitation, leading to increased healthcare costs and a lower quality of life. Current treatments like medication and injections have significant drawbacks, such as side effects and high costs, creating a need for new, non-invasive, and effective methods. The study highlights that traditional methods for assessing spasticity, like the Modified Ashworth Scale (MAS), are subjective. It proposes using objective, non-invasive ultrasound techniques-specifically strain elastography (to measure muscle stiffness) and echogenicity (to assess muscle tissue quality)-for a more reliable evaluation. The primary goal of this research is to be the first to investigate the short- and long-term effects of ESWT on the FCR and FCU muscles using these objective ultrasound measures alongside traditional clinical scales. The findings are expected to help standardize ESWT treatment protocols and promote the use of objective ultrasound data for the management and follow-up of post-stroke spasticity.

Вмешательства

• Устройство Radial Extracorporeal Shock Wave Therapy
  rESWT will be administered to the FCU and FCR muscles two days per week over a period of four weeks (8 sessions in total). The point of application will be selected as the center of the muscle belly for both the FCU and FCR. Each muscle will receive 2000 shocks using a 15 mm applicator tip at a frequency of 5 Hz. The treatment will be conducted at an intensity of 60 mJ (1 bar), with an energy flux density of 0.340 mJ/mm².
• Другое Conventional rehabilitation
  Conventional rehabilitation will be administered for 1-2 hours daily, 5 days a week, for 12 weeks. It will include range of motion exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight shifting, balance, gait training, occupational therapy, and speech-language therapy according to the patient's needs.

Первичные конечные точки

• Modified Ashworth Scale [Срок оценки: Baseline, 4th week, 8th week and 12th week after treatment.]

Вторичные конечные точки (5)

• Wrist range of motion [Срок оценки: Baseline 4th week 8th week and 12th week after treatment.]
• Modified Barthel Index [Срок оценки: Baseline, 4th week, 8th week and 12th week after treatment.]
• The Fugl-Meyer Upper Extremity Scale [Срок оценки: Baseline, 4th week, 8th week and 12th week after treatment.]
• Modified Heckmatt Scale [Срок оценки: Baseline, 4th week, 8th week and 12th week after treatment.]
• Sonoelastographic strain index [Срок оценки: Baseline, 4th week, 8th week and 12th week after treatment.]

Критерии участия

Критерии включения

• Age between 35 and 65 years.
• First-ever stroke episode confirmed by MRI and/or CT scan.
• Clinical diagnosis of hemiplegia.
• More than 6 months post-stroke.
• A Modified Ashworth Scale (MAS) score between 1 and 3 for wrist flexor spasticity.

Критерии исключения

• History of more than one stroke episode
• Stroke onset more than ten years ago
• Stroke onset less than 6 months ago
• Age over 65 (to limit the effects of aging on muscle structure)
• Contraindications for ESWT (e.g., cancer, local tumor or active infection in the treatment area, pregnancy, coagulation disorders, pacemaker or other electronic/metallic implants)
• Severe aphasia or serious communication problems
• Presence of fixed contracture in the wrist
• Patients who have received botulinum toxin or phenol nerve block injections within the last 6 months
• Medically unstable patients (e.g., uncontrolled hypertension, diabetes mellitus, or severe cardiac, hepatic, or renal disease)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Pamukkale University — Denizli

Идентификаторы

NCT: NCT07119801 · PamukkaleU.ftr-MGAkıncı-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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