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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365476
• Other study ID #: 202309126RIND
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: April 15, 2027

Study information

• Verified date: November 2023
• Source: National Taiwan University Hospital
• Contact: Shu-mei Yang, MD
• Phone: 886-0972653754
• Email: b99401109[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 15, 2027
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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 Reha — View 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. — View 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.jstr — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)	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
Secondary	Action Research Arm Test (ARAT)	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
Secondary	Barthel index	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
Secondary	Functional Independence Measure (FIM)	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
Secondary	ultrasound assessment	used strain elastography to assess elasticity of forearm muscles	pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Secondary	Box and Block Test	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
Secondary	Wolf Motor Function Test	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