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

NCT07532187 | Completed

• 1 other identifier: BLG-STROKE-2026
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

rEswt; stroke; hemiplegia; spasticity; upper extremity; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change from baseline in functional independence

  Baseline, at 4 weeks and at 12 weeks follow-up

• Change from baseline in pain intensity

  Baseline, at 4 weeks and at 12 weeks follow-up

• Change from baseline in stroke-specific quality of life

  Baseline, at 4 weeks and at 12 weeks follow-up

• Change from baseline in depressive symptom severity

  Baseline, at 4 weeks, and at 12 weeks follow-up

• Change from baseline in proprioception

  Baseline, at 4 weeks and at 12 weeks follow-up

Study Arms (1)

Radial Extracorporeal Shock Wave Therapy (rESWT)

EXPERIMENTAL

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)

Interventions

Radial Extracorporeal Shock Wave Therapy (rESWT) DEVICE

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.

Radial Extracorporeal Shock Wave Therapy (rESWT)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, Istanbul, 34785, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants received radial extracorporeal shock wave therapy (rESWT) applied to the affected upper extremity. rESWT was delivered to three muscle groups - biceps brachii, flexor carpi radialis, and flexor carpi ulnaris - at standardized anatomical target points defined according to the EUROMUSCULUS/USPRM guideline. Treatment parameters were 2,000 impulses per muscle group, 5 Hz frequency, and 1.5 bar pressure, administered twice weekly for 4 weeks (8 sessions total). No concurrent antispastic medication or botulinum toxin injection was permitted during the study period. Outcomes were assessed at three time points: baseline, week 4, and week 12.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: July 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)