Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity

NCT07119801 | Recruiting

• 1 other identifier: PamukkaleU.ftr-MGAkıncı-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Spastic Hemiplegia; Extracorporal Shockwave Therapy (ESWT)

Keywords

spastic hemiplegia; extracorporeal shockwave therapy; spasticity of the wrist flexors

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale

  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.

  Baseline, 4th week, 8th week and 12th week after treatment.

Secondary Outcomes (5)

• Wrist range of motion

  Baseline 4th week 8th week and 12th week after treatment.

• Modified Barthel Index

  Baseline, 4th week, 8th week and 12th week after treatment.

• The Fugl-Meyer Upper Extremity Scale

  Baseline, 4th week, 8th week and 12th week after treatment.

• Modified Heckmatt Scale

  Baseline, 4th week, 8th week and 12th week after treatment.

• Sonoelastographic strain index

  Baseline, 4th week, 8th week and 12th week after treatment.

Study Arms (2)

Conventional group

ACTIVE COMPARATOR

This group will receive physical therapy for 1-2 hours daily, 5 days a week, for 12 weeks. The therapy will include range of motion (ROM) exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-bearing exercises, balance and gait training, and occupational therapy. Speech and language therapy will also be included according to the patient's needs.

Other: Conventional rehabilitation

radial ESWT (rESWT) plus conventional rehabilitation group

EXPERIMENTAL

The rESWT will be applied to the Flexor Carpi Ulnaris (FCU) and Flexor Carpi Radialis (FCR) muscles twice a week for four weeks, totaling eight sessions. The application site will be the midpoint of the most prominent part of each muscle. For each muscle, a 15 mm applicator head will be used to deliver 2000 impulses at a frequency of 5 Hz and an intensity of 60 mJ (1 bar), corresponding to an energy flux density of 0.340 mJ/mm². Additionally, this group will receive physical therapy for 1-2 hours daily, 5 days a week, for 12 weeks. The therapy will include range of motion (ROM) exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-bearing exercises, balance and gait training, and occupational therapy. Speech and language therapy will also be included according to the patient's needs.

Device: Radial Extracorporeal Shock Wave Therapy; Other: Conventional rehabilitation

Interventions

Radial Extracorporeal Shock Wave Therapy DEVICE

rESWT will be administered to the FCU and FCR muscles two days per week over a period of four weeks (8 sessions in total). The point of application will be selected as the center of the muscle belly for both the FCU and FCR. Each muscle will receive 2000 shocks using a 15 mm applicator tip at a frequency of 5 Hz. The treatment will be conducted at an intensity of 60 mJ (1 bar), with an energy flux density of 0.340 mJ/mm².

radial ESWT (rESWT) plus conventional rehabilitation group

Conventional rehabilitation OTHER

Conventional rehabilitation will be administered for 1-2 hours daily, 5 days a week, for 12 weeks. It will include range of motion exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight shifting, balance, gait training, occupational therapy, and speech-language therapy according to the patient's needs.

Conventional group; radial ESWT (rESWT) plus conventional rehabilitation group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke; Hemiplegia

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

Study Officials

• Meltem Güneş Akıncı, Assistant professor

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Meltem Güneş Akıncı, Assistant professor

CONTACT

+905375145590; meltem_aytekin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: September 5, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-08

Locations

TU (1)