FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity

Официальное название

Effects of Extracorporeal Shock Wave for Upper Limb Flexor Spasticity in Stroke Patients: A Randomized Controlled Trial

Обзор

Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.

Подробное описание

This study aimed to evaluate the effects of focused Extracorporeal Shock Wave Therapy (ESWT) on upper limb flexor spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific forearm flexor muscles, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.

The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, hand grip strength, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, ultrasound strain elastography, and electromyography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on upper limb function and spasticity in stroke survivors.

Вмешательства

• Устройство focused extracorporeal shock wave therapy (ESWT)
  The focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis.

Первичные конечные точки

• passive range of motion for the wrist and finger joints [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• hand grip strength [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• Visual Analogue Scale (VAS) [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• modified Ashworth scale (MAS) [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• modified Tardieu scale (MTS) [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]

Вторичные конечные точки (7)

• Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• Action Research Arm Test (ARAT) [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• Barthel index [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• Functional Independence Measure (FIM) [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• ultrasound assessment [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• Box and Block Test [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• Wolf Motor Function Test [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]

Критерии участия

Критерии включения

• Individuals aged 18 years or older with unilateral cerebral stroke.
• Wrist and finger flexor muscle tone with a score greater than 1 on the Modified Ashworth Scale.
• Stable medical condition and vital signs.
• Conscious and able to comply with instructions.

Критерии исключения

• History of more than one stroke, traumatic brain injury, or cerebral neoplasm.
• Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal diseases affecting muscle tone assessment.
• Contraindications for shockwave intervention, such as malignancies, coagulopathies, local infections, or use of cardiac pacemakers.
• Undergone shockwave therapy or botulinum toxin injections for post-stroke spasticity in the past three months.
• Cognitive, consciousness, or language impairments preventing participation in the intervention or functional assessments.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital — Taipei

Публикации

• Dymarek R, Taradaj J, Rosinczuk J. Extracorporeal Shock Wave Stimulation as Alternative Treatment Modality for Wrist and Fingers Spasticity in Poststroke Patients: A Prospective, Open-Label, Preliminary Clinical Trial. Evid Based Complement Alternat Med. 2016;2016:4648101. doi: 10.1155/2016/4648101. Epub 2016 Jul 18. PMID 27504139
• Cabanas-Valdes R, Calvo-Sanz J, Urrutia G, Serra-Llobet P, Perez-Bellmunt A, German-Romero A. The effectiveness of extracorporeal shock wave therapy to reduce lower limb spasticity in stroke patients: a systematic review and meta-analysis. Top Stroke Rehabil. 2020 Mar;27(2):137-157. doi: 10.1080/10749357.2019.1654242. Epub 2019 Nov 11. PMID 31710277
• Yasar E, Adiguzel E, Kesikburun S, Yenihayat I, Yilmaz B, Alaca R, Tan AK. Assessment of forearm muscle spasticity with sonoelastography in patients with stroke. Br J Radiol. 2016 Dec;89(1068):20160603. doi: 10.1259/bjr.20160603. Epub 2016 Oct 25. PMID 27679870
• Jia G, Ma J, Wang S, Wu D, Tan B, Yin Y, Jia L, Cheng L. Long-term Effects of Extracorporeal Shock Wave Therapy on Poststroke Spasticity: A Meta-analysis of Randomized Controlled Trials. J Stroke Cerebrovasc Dis. 2020 Mar;29(3):104591. doi: 10.1016/j.jstrokecerebrovasdis.2019.104591. Epub 2019 Dec 31. PMID 31899073

Идентификаторы

NCT: NCT06365476 · 202309126RIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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