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

NCT ID: NCT07119801

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-05
• Study Completion Date: 2026-08-20

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional group

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.

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type: 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.

radial ESWT (rESWT) plus conventional rehabilitation group

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.

Group Type: EXPERIMENTAL

Radial Extracorporeal Shock Wave Therapy

Intervention Type: 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.

Conventional rehabilitation

Intervention Type: 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.

Interventions

Radial Extracorporeal Shock Wave Therapy

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.

Intervention Type: DEVICE

Conventional rehabilitation

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Meltem Gunes Akinci

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meltem Güneş Akıncı, Assistant professor

Role: STUDY_DIRECTOR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Meltem Güneş Akıncı, Assistant professor

Role: CONTACT

meltem_aytekin@hotmail.com

+905375145590

Facility Contacts

Atakan Yenidünya, Resident physician

Role: primary

tknyndny@gmail.xom

+905373303225

Other Identifiers

PamukkaleU.ftr-MGAkıncı-001

Identifier Type: -

Identifier Source: org_study_id