Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: fESWT.
- Кому может быть актуально
- Состояния в реестре: Stroke, Equinus Deformity, Spasticity, Muscle. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effects of Focused Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients: a Randomized Controlled Trial
Обзор
The goal of this study is to evaluate long term effects of focused extracorporeal shock wave therapy (fESWT) on triceps surae spasticity in stroke patients according to the number of sessions applied. Hypothesis: 3 sessions of fESWT on equinus foot in stroke patients improve spasticity and functionality for longer term than 1 session of fESWT.
Подробное описание
Spasticity is a common complication as a consequence of suffering a stroke and one of the most important causes of disability in this pathology.
Global data estimate that 12 million people world-wide suffer from spasticity of the upper or lower limb. Equinus foot is the most common pattern of the lower extremities.
Previous studies have reported that extracorporeal shock wave therapy (ESWT) is a safe and noninvasive alternative treatment for spasticity.
Although the authors have shown a beneficial clinical effect of the ESWT, outcomes and duration of effect varied across studies.
This is a prospective randomized controlled trial. 60 stroke patients with spastic equinus foot post stroke will enroll in this study.
The participants will be randomly divided into two groups. The first group (control group) will receive 1 session of fESWT, while the second group (experimental group) will receive 3 sessions of fESWT, once a week, for 3 consecutive weeks.
Therapy will be administered directly to the muscle bellies of the gastrocnemius medial and lateral and soleus. The muscle belly will be located by ultrasonography.
The primary outcome is modified Ashworth scale. Secondary outcomes are passive range of ankle motion, mobility and balance test, spasm frequency scale and quality of life scales.
Participants will be evaluated by the same researcher before the first shock wave therapy and after the last session of fESWT will be done periodic revisions on weeks 1, 4, 8, 12, 20, 24, 36 and 48. Adverse events will be monitored during the study.
Вмешательства
- Устройство fESWT
Shock wave therapy will be applied with Duolith SD1 device (Storz Medical, Tagerwilen, Switzerland). Therapy will be administered in the gastrocnemius medial and lateral and in the soleus muscles. Parameters: 0.15mJ/mm2, 4-5 Hz, 1500 shoots/muscle.
Первичные конечные точки
- Modified Ashworth Scale (MAS) [Срок оценки: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.]
Вторичные конечные точки (9)
- Passive Ankle range of motion (PROM) [Срок оценки: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.]
- Visual Analogue Scale (VAS) Pain Score [Срок оценки: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.]
- 10 Meters Walk Test [Срок оценки: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.]
- Test Up and Go (TUG) [Срок оценки: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.]
- Spasm Frequency Scale [Срок оценки: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.]
- Test 6 Minutes Walking [Срок оценки: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.]
- Fall Skip Device [Срок оценки: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.]
- Stroke Quality of Life Scale (ECVI-38) [Срок оценки: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.]
- Self Report Spasticity Scale (SRSS) [Срок оценки: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.]
Критерии участия
Критерии включения
- Age greater than 18 years old
- Time from stroke (ischemic o hemorrhagic) onset of at least 6 months
- Spastic equinus foot: triceps surae tone grade at least 1+ on the MAS score
- Ability to walk alone with or without aids
Критерии исключения
- Fixed ankle joint contracture
- Severe medical problems
- Treatment of the affected leg with botulinum toxin in the las 6 months
- Cognitive impairment
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Испания · 1 центр
- Hospital de la Plana — Vila-real
Публикации
- Guo P, Gao F, Zhao T, Sun W, Wang B, Li Z. Positive Effects of Extracorporeal Shock Wave Therapy on Spasticity in Poststroke Patients: A Meta-Analysis. J Stroke Cerebrovasc Dis. 2017 Nov;26(11):2470-2476. doi: 10.1016/j.jstrokecerebrovasdis.2017.08.019. Epub 2017 Sep 13. PMID 28918085
- Lee JY, Kim SN, Lee IS, Jung H, Lee KS, Koh SE. Effects of Extracorporeal Shock Wave Therapy on Spasticity in Patients after Brain Injury: A Meta-analysis. J Phys Ther Sci. 2014 Oct;26(10):1641-7. doi: 10.1589/jpts.26.1641. Epub 2014 Oct 28. PMID 25364134
- Taheri P, Vahdatpour B, Mellat M, Ashtari F, Akbari M. Effect of Extracorporeal Shock Wave Therapy on Lower Limb Spasticity in Stroke Patients. Arch Iran Med. 2017 Jun;20(6):338-343. PMID 28646841
Идентификаторы
NCT: NCT06547684 · TMC-OCF-2019-02