Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity: A Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Stroke; Spastic Hemiplegia; Extracorporal Shockwave Therapy (ESWT)

• Registration Number: NCT07119801
• Lead Sponsor: Pamukkale University

Brief Summary

This research evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) for treating spasticity in the wrist flexor muscles (flexor carpi ulnaris - FCU and flexor carpi radialis - FCR) of chronic stroke patients.

Spasticity, a common complication after a stroke, causes muscle stiffness, pain, and functional limitation, leading to increased healthcare costs and a lower quality of life. Current treatments like medication and injections have significant drawbacks, such as side effects and high costs, creating a need for new, non-invasive, and effective methods.

The study highlights that traditional methods for assessing spasticity, like the Modified Ashworth Scale (MAS), are subjective. It proposes using objective, non-invasive ultrasound techniques-specifically strain elastography (to measure muscle stiffness) and echogenicity (to assess muscle tissue quality)-for a more reliable evaluation.

The primary goal of this research is to be the first to investigate the short- and long-term effects of ESWT on the FCR and FCU muscles using these objective ultrasound measures alongside traditional clinical scales. The findings are expected to help standardize ESWT treatment protocols and promote the use of objective ultrasound data for the management and follow-up of post-stroke spasticity.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-08-20
• Primary Completion: 2026-04-20
• Study Completion: 2026-08-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Age between 35 and 65 years.

First-ever stroke episode confirmed by MRI and/or CT scan.

Clinical diagnosis of hemiplegia.

More than 6 months post-stroke.

A Modified Ashworth Scale (MAS) score between 1 and 3 for wrist flexor spasticity.

Exclusion Criteria

History of more than one stroke episode

Stroke onset more than ten years ago

Stroke onset less than 6 months ago

Age over 65 (to limit the effects of aging on muscle structure)

Contraindications for ESWT (e.g., cancer, local tumor or active infection in the treatment area, pregnancy, coagulation disorders, pacemaker or other electronic/metallic implants)

Severe aphasia or serious communication problems

Presence of fixed contracture in the wrist

Patients who have received botulinum toxin or phenol nerve block injections within the last 6 months

Medically unstable patients (e.g., uncontrolled hypertension, diabetes mellitus, or severe cardiac, hepatic, or renal disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Modified Ashworth Scale	Baseline, 4th week, 8th week and 12th week after treatment.	The Ashworth Scale assesses the resistance encountered when an evaluator moves a limb through its full range of motion.; According to the Modified Ashworth Scale: 0: No increase in muscle tone.; 1: Slight increase in muscle tone, characterized by a catch and release or by minimal resistance at the end of the range of motion.; 1+: Slight increase in muscle tone, characterized by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion.; 2: More marked increase in muscle tone throughout most of the range of motion, but the affected part(s) can be moved easily.; 3: Considerable increase in muscle tone; passive movement is difficult.; 4: Affected part(s) are rigid in flexion or extension.

Secondary Outcome Measures

Name	Time	Method
Wrist range of motion	Baseline 4th week 8th week and 12th week after treatment.	During the measurement, the goniometer is aligned with the joint's axis of rotation to determine the maximum angle during passive movement. It is crucial that the limb is moved slowly and carefully to avoid eliciting resistance from the patient's spastic muscles. A slow, controlled movement minimizes spasticity, thereby ensuring a more accurate measurement.Wrist passive range of motion will be measured.
Modified Barthel Index	Baseline, 4th week, 8th week and 12th week after treatment.	The Barthel Index (BI) consists of 10 items related to mobility and activities of daily living (ADL), and it assesses activities such as feeding, transfer from wheelchair to bed and back, personal grooming, bathing, walking, ascending and descending stairs, dressing, and bladder and bowel continence.; The Modified Barthel Index (MBI) is a revision of the original Barthel Index (BI) and uses the same 10 items. The main difference between these two measures is that the MBI consistently classifies patient performance into five scoring levels: unable to perform the task, attempts the task but is unsafe, moderate assistance required, minimal assistance required, and fully independent. The total score of the MBI also ranges from 0 to 100, with higher scores indicating greater independence in ADL.
The Fugl-Meyer Upper Extremity Scale	Baseline, 4th week, 8th week and 12th week after treatment.	The Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) is designed to quantitatively evaluate the motor function of stroke patients and includes tests for upper extremity motor and sensory function. The FMA-UE is used to assess upper extremity motor impairment and contains 33 items scored on a scale from 0 to 2 (0 = cannot perform, 1 = performs partially, and 2 = performs fully), with a total score range of 0-66. The FMA has been reported to have high reliability for testing motor performance in post-stroke patients.
Modified Heckmatt Scale	Baseline, 4th week, 8th week and 12th week after treatment.	he Modified Heckmatt Scale is a method that uses ultrasonography to reliably evaluate echogenic changes in a spastic muscle, thereby indicating the level of fibrotic change. The Modified Heckmatt Scale was developed to achieve greater sensitivity between grades compared to the original Heckmatt Scale, particularly for muscles with mildly to moderately increased echo intensity (Grades 2 and 3).; Grade 1: Normal echogenicity, distinct from the bone echo, is observed in over 90% of the muscle.; Grade 2: There is increased muscle echogenicity in 10-50% of the tissue, but a distinct bone echo and areas of normal muscle echo are still present.; Grade 3: A marked increase in muscle echogenicity is seen in 50% to 90% of the tissue, with reduced differentiation of the bone echo from the muscle.; Grade 4: Very strong muscle echogenicity is observed in \>90% of the tissue, with a near-complete loss of the distinct bone echo from the muscle.
Sonoelastographic strain index	Baseline, 4th week, 8th week and 12th week after treatment.	Quantitative elastography analysis will be used to measure stiffness. As a software feature of the ultrasound system, quantitative elastography analysis numerically measures the color distribution in a selected area across single or multiple frames and calculates an elasticity index for the measured area.; The elasticity index is a value between 0.0 and 6.0, generated by the reflected color distribution within the selected region. A higher value signifies greater stiffness, which is predominantly represented by the color blue on the screen. While the elasticity index is calculated separately for the reference area and the muscle, the system automatically calculates the strain ratio as muscle/reference area.