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

National Taiwan University

Status: Enrolling

Conditions: Spasticity, Muscle; Stroke

Treatments: Device: focused extracorporeal shock wave therapy (ESWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06365476

202309126RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Focused Extracorporeal Shock Wave Therapy

Experimental group

Description:

Participants in this arm will receive focused Extracorporeal Shock Wave Therapy (ESWT) targeting three specific muscles: the flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis. Each muscle will receive 1,500 shockwave shots per session, accumulating to a total of 4,500 shots across all targeted muscles in each session. The treatment will be administered twice a week for two consecutive weeks, resulting in a total of four treatment sessions.

Treatment:

Device: focused extracorporeal shock wave therapy (ESWT)

Placebo-Controlled Shockwave Therapy

Placebo Comparator group

Description:

Participants in this arm will receive placebo-controlled focused ESWT, mirroring the treatment protocol of the experimental group but without the application of active shockwaves.

Treatment:

Device: focused extracorporeal shock wave therapy (ESWT)