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

NCT06365476 | Recruiting

• 1 other identifier: 202309126RIND
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Spasticity, Muscle

Keywords

stroke; spasticity; shock wave; wrist; finger

Outcome Measures

Primary Outcomes (5)

• passive range of motion for the wrist and finger joints

  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

  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)

  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)

  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)

  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 Outcomes (7)

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

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

• Action Research Arm Test (ARAT)

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

• Barthel index

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

• Functional Independence Measure (FIM)

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

• ultrasound assessment

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

Study Arms (2)

Focused Extracorporeal Shock Wave Therapy

EXPERIMENTAL

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)

Placebo-Controlled Shockwave Therapy

PLACEBO COMPARATOR

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)

Interventions

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.

Focused Extracorporeal Shock Wave Therapy; Placebo-Controlled Shockwave Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Shu-mei Yang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-mei Yang, MD

CONTACT

886-0972653754; b99401109@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: April 15, 2024
• Primary Completion: April 15, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: July 29, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)