Clinical trial NCT06365476: FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity
Official title: Effects of Extracorporeal Shock Wave for Upper Limb Flexor Spasticity in Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Spasticity, Muscle
Keywords: stroke
spasticity
shock wave
wrist
finger
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: passive range of motion for the wrist and finger joints
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: hand grip strength
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: Visual Analogue Scale (VAS)
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: modified Ashworth scale (MAS)
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: modified Tardieu scale (MTS)
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Secondary outcomes:
measure: Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: Action Research Arm Test (ARAT)
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: Barthel index
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: Functional Independence Measure (FIM)
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: ultrasound assessment
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: Box and Block Test
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: Wolf Motor Function Test
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shu-mei Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.