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NCT Number: NCT06365476

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity, Muscle Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital

Taipei, 100, Taiwan

Location status: Recruiting

Location contact

Shu-mei Yang, MD

CONTACT

[email protected]

886-2- 23123456

Shu-mei Yang, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

focused extracorporeal shock wave therapy (ESWT)

Device

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.

Primary outcomes

  1. passive range of motion for the wrist and finger joints

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    the extent to which a joint can be moved without the patient actively participating in the movement

  2. hand grip strength

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    use dynamometer to record the maximum force applied when the patient squeezes it

  3. Visual Analogue Scale (VAS)

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable

  4. modified Ashworth scale (MAS)

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    Evaluate spasticity in individuals with neurological conditions. The scale ranges from 0, indicating no increase in muscle tone, to 4, which represents severe spasticity with affected parts rigid in flexion or extension.

  5. modified Tardieu scale (MTS)

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    A standard goniometer will be utilized to measure R2 and R1. The patient will be in testing position according to the muscle to be tested. The stretching velocity of V1 and V3 will be applied to measure R2 and R1, respectively. The quality of muscle reaction will be graded at the stretching velocity of V3 as well. The difference between R2 and R1 will be the measure of the dynamic component of spasticity. The minimum score on the MTS is 0 (no spasticity), and the maximum score is 5 (severe spasticity), for each of the velocities tested.

Secondary outcomes

  1. Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    range from 0 (complete paralysis) to 66 (full function), assessing motor recovery in post-stroke upper extremities

  2. Action Research Arm Test (ARAT)

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    a standardized measure evaluating upper limb motor ability in stroke patients, scoring from 0 (no movement) to 57 (normal arm function). It assesses grasp, grip, pinch, and gross arm movement.

  3. Barthel index

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    measures a person's daily living abilities, focusing on ten areas of self-care and mobility. Scores range from 0 to 100, with higher scores denoting greater independence.

  4. Functional Independence Measure (FIM)

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    assesses a patient's level of disability and tracks changes over time, with a focus on physical and cognitive functioning across 18 items, scored from 18 (total assistance required) to 126 (fully independent).

  5. ultrasound assessment

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    used strain elastography to assess elasticity of forearm muscles

  6. Box and Block Test

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    a manual dexterity test where participants transfer wooden blocks from one section of a box to another for one minute using one hand. The score is determined by the number of blocks moved, with minimal scores indicating severe dexterity impairment and higher scores indicating better gross manual dexterity.

  7. Wolf Motor Function Test

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    assess upper extremity function in individuals with neurological impairments, using 17 tasks divided into sections of time, functional ability, and strength. Scoring is on a 6-point ordinal scale, ranging from 0 ("Does not attempt with upper extremity being tested," indicating severe impairment) to 5 ("Movement appears to be normal," suggesting full functionality). Lower scores indicate greater impairment.

Study contacts

Contact information is provided by the study sponsor or research team.

Shu-mei Yang, MD

CONTACT

[email protected]

886-0972653754

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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