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

July 27, 2025 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Shu-mei Yang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Focused Extracorporeal Shock Wave Therapy
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.
Device: 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.
Placebo Comparator: Placebo-Controlled Shockwave Therapy
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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.
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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.
pre-treatment; 1, 4, 12, and 24 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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.
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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.
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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).
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
ultrasound assessment
Time Frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
used strain elastography to assess elasticity of forearm muscles
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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.
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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.
pre-treatment; 1, 4, 12, and 24 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Shu-mei Yang, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 27, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202309126RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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