THE EFFECTS OF EXTRACORPOREAL SHOCK WAVE THERAPY ON UPPER EXTREMITY SPASTICITY AND FUNCTION IN PATIENTS WITH STROKE

THE EFFECTS OF EXTRACORPOREAL SHOCK WAVE THERAPY ON UPPER EXTREMITY SPASTICITY AND FUNCTION IN PATIENTS WITH STROKE: A SINGLE-ARM STUDY

Stroke is a leading cause of adult disability worldwide. Among its most functionally limiting complications is upper extremity spasticity - a velocity-dependent increase in muscle tone that restricts arm and hand function, impairs daily activities, and reduces quality of life. Current treatment options such as oral antispastic agents and botulinum toxin injections are associated with systemic side effects, high cost, invasiveness, or short duration of effect.

Radial extracorporeal shock wave therapy (rESWT) is a non-invasive modality that delivers acoustic pressure waves to target tissues and has shown promising antispastic effects through both neural and biomechanical mechanisms.

This prospective observational study (N=21) evaluates the effects of upper extremity rESWT on spasticity, pain, motor function, functional independence, and quality of life in individuals with post-stroke hemiplegia. rESWT was applied to three muscle groups (biceps brachii, flexor carpi radialis, and flexor carpi ulnaris) at 2,000 impulses per muscle, 5 Hz, 1.5 bar, twice weekly for 4 weeks (8 sessions total). Outcomes were assessed at three time points: baseline, month 1, and month 3.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Radial Extracorporeal Shock Wave Therapy (rESWT)

Detailed Description

Stroke ranks first among causes of adult disability and second among causes of mortality worldwide. Post-stroke spasticity develops in 4% to 50% of patients within the first six months after stroke, depending on lesion localization and timing of assessment. In the upper extremity, spasticity typically manifests as shoulder adduction and internal rotation, elbow flexion, forearm pronation, and wrist/finger flexion severely limiting functional use of the hand and arm. Associated pain, spasms, and joint contractures further reduce quality of life and rehabilitation motivation.

Conventional antispastic treatments carry notable limitations: oral agents produce sedation and generalized muscle weakness; botulinum toxin injections are costly, invasive, limited in duration, and carry a risk of neutralizing antibody development with repeated use. These limitations have prompted growing interest in rESWT as a non-invasive, low-side-effect alternative with multifactorial antispastic mechanisms, including modulation of motor neuron excitability, improvement of passive muscle elasticity through fibrolytic effects, and facilitation of autogenic inhibition via Golgi tendon organ stimulation.

Study Design: Single-arm prospective observational study. Approved by the Ethics Committee of Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital (Decision No: 2025/214; Date: 11.06.2025). All procedures were conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.

Participants (N=21): Adults (≥18 years) with post-stroke hemiplegia of at least 4 weeks duration, Modified Ashworth Scale (MAS) score ≥2 in at least one upper extremity joint movement, and sufficient cognitive ability to follow simple commands.

Exclusion criteria included consciousness impairment, systemic contraindications to ESWT, shoulder subluxation on the affected side, skin integrity disruption at the application site, and botulinum toxin injection within the preceding 3 months.

Intervention: rESWT was applied to three muscle groups of the affected upper extremity - biceps brachii, flexor carpi radialis (FCR), and flexor carpi ulnaris (FCU) - using the following parameters: 2,000 impulses per muscle group, 5 Hz frequency, 1.5 bar pressure. Treatment was administered twice weekly for 4 weeks (8 sessions total). Anatomical target points were standardized according to the EUROMUSCULUS/USPRM guideline.

Outcome Measures: All assessments were performed at three time points: baseline (before rESWT initiation), month 1. and month 3.

Spasticity: Modified Ashworth Scale (MAS) Upper extremity motor function: Fugl-Meyer Upper Extremity Scale Functional independence: Modified Barthel Index Pain: Visual Analog Scale (VAS) Stroke-specific quality of life: Stroke Specific Quality of Life Scale (SSQLS) Proprioception: Clinical joint position sense assessment (categorized as intact, impaired, or not assessable)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34785
      • Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• Diagnosis of hemiplegia following stroke
• Minimum of 4 weeks elapsed since stroke onset
• Modified Ashworth Scale (MAS) score ≥ 2 in at least one upper extremity joint movement
• Sufficient cognitive ability to follow simple commands
• No botulinum toxin injection in the preceding 3 months
• Willing to participate and signed informed consent form

Exclusion Criteria:

• Impaired consciousness or severe cognitive deficit
• Systemic conditions contraindicating ESWT (active infection, malignancy, etc.)
• Shoulder subluxation on the affected side
• Skin integrity disruption at the application site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radial Extracorporeal Shock Wave Therapy (rESWT); Participants received radial extracorporeal shock wave therapy applied to three muscle groups of the affected upper extremity (biceps brachii, flexor carpi radialis, and flexor carpi ulnaris) at 2,000 impulses per muscle group, 5 Hz frequency, and 1.5 bar pressure, twice weekly for 4 weeks (8 sessions total)	Device: Radial Extracorporeal Shock Wave Therapy (rESWT); rESWT was delivered to the biceps brachii, flexor carpi radialis, and flexor carpi ulnaris of the affected upper extremity. Parameters: 2,000 impulses per muscle group, 5 Hz, 1.5 bar. Eight sessions administered twice weekly over 4 weeks. Anatomical target points were standardized according to the EUROMUSCULUS/USPRM guideline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in upper extremity spasticity	Spasticity will be assessed using the Modified Ashworth Scale (MAS). Passive resistance is graded on a 0-4 ordinal scale across seven upper extremity movements: elbow flexion/extension, forearm pronation/supination, wrist flexion/extension, and finger flexion. Higher scores indicate greater spasticity.	Baseline, at 4 weeks and 12 weeks follow-up
Change from baseline in upper extremity motor function	Assessed using the Fugl-Meyer Upper Extremity Scale (FMA-UE), a 33-item scale scoring voluntary movement, reflexes, coordination, and independent joint motion.	Baseline, at 4 weeks and 12 weeks follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in functional independence	Assessed using the Modified Barthel Index (MBI), evaluating 10 daily living activities on a scale of 0-100. Higher scores indicate greater independence.	Baseline, at 4 weeks and at 12 weeks follow-up
Change from baseline in pain intensity	Assessed using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates unbearable pain, measured at rest and during activity.	Baseline, at 4 weeks and at 12 weeks follow-up
Change from baseline in stroke-specific quality of life	Assessed using the Stroke Specific Quality of Life Scale (SSQLS), a 49-item instrument covering 12 domains scored on a 1-5 Likert scale. Higher scores indicate better quality of life.	Baseline, at 4 weeks and at 12 weeks follow-up
Change from baseline in depressive symptom severity	Assessed using the Beck Depression Inventory (BDI). Higher scores indicate greater depressive symptom severity.	Baseline, at 4 weeks, and at 12 weeks follow-up
Change from baseline in proprioception	Joint position sense of the affected upper extremity assessed via standard clinical examination, categorized as intact, impaired, or not assessable.	Baseline, at 4 weeks and at 12 weeks follow-up

Collaborators and Investigators

• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; hemiplegia; spasticity; upper extremity; rEswt
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Stroke; Hemiplegia
• Other Study ID Numbers: BLG-STROKE-2026

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