Effect of rESWT Session Frequency on Spasticity and Function Assessed by Sonoelastography in Children With Cerebral Palsy (CP-rESWT-FREQ)

Sisli Hamidiye Etfal Training and Research Hospital

Status: Enrolling

Conditions: Cerebral Palsy (CP)

Treatments: Other: Conventional physical therapy; Device: Real radial extracorporeal shock wave therapy (rESWT); Device: Sham radial extracorporeal shock wave therapy (rESWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07476690

2024-KAEK-31 (Registry Identifier)

CP-rESWT-SessionFreq-RCT-TR-01

Details and patient eligibility

About

Spasticity is a major contributor to functional limitations in children with cerebral palsy. Radial extracorporeal shock wave therapy (rESWT) has emerged as a non-invasive method for reducing spasticity; however, the optimal session frequency remains unclear. This randomized, assessor-blinded, parallel-group controlled trial investigates the effects of different rESWT session frequencies on spasticity, motor function, balance, pain, and muscle properties in children with cerebral palsy.

Participants are randomly assigned to three groups receiving sham rESWT, one real rESWT session per week combined with sham, or two real rESWT sessions per week, in addition to routine neurological rehabilitation. Outcomes are assessed using clinical scales and ultrasonography-based measures, including shear wave elastography. The study aims to define the dose-response relationship of rESWT and inform optimal treatment protocols in pediatric neurorehabilitation.

Full description

Cerebral palsy is the most common cause of childhood physical disability, and spasticity represents one of its most prominent and disabling features. Increased muscle tone negatively affects mobility, balance, and functional independence and may lead to secondary musculoskeletal complications. Although pharmacological and surgical interventions are available, there is a growing need for non-invasive, easily applicable, and safe treatment options in pediatric neurorehabilitation. Radial extracorporeal shock wave therapy (rESWT) has gained attention as a promising modality for reducing spasticity and improving muscle properties. Previous studies have demonstrated beneficial effects of rESWT in children with cerebral palsy; however, there is no consensus regarding the optimal treatment frequency and dosing strategy. Determining the most effective session frequency is essential to maximize clinical benefit while minimizing treatment burden. By comparing different rESWT session frequencies, this study aims to define a dose-response relationship and identify the most effective treatment strategy. The findings are expected to contribute to evidence-based optimization of rESWT protocols in pediatric neurorehabilitation and to improve functional outcomes in children with cerebral palsy. This study is designed as a prospective, randomized, double-blind, parallel-group controlled clinical trial conducted at the University of Health Sciences, Sisli Hamidiye Etfal Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Participants are recruited from children presenting to the outpatient clinic who meet the inclusion criteria and none of the exclusion criteria. The study follows a double-blind protocol. Except for the operator delivering the intervention, all individuals involved in the study-including participants and outcome assessors-are blinded to the session type (real versus sham rESWT). This design ensures unbiased outcome assessment and minimizes expectancy effects. All participants continue routine neurological rehabilitation consisting of conventional physical therapy for 60 minutes per session, three sessions per week for 12 weeks. In addition, during the first three weeks, all groups attend the research center two days per week for rESWT or sham procedures combined with standardized stretching. In participants with bilateral plantar flexor spasticity, the lower extremity with the highest initial Modified Ashworth Scale (MAS) score will be taken as the basis for evaluation purposes. However, to preserve functional integrity and avoid ethical concerns, rESWT will be applied equally to both lower extremities. rESWT applications will be carried out targeting the motor end-plate zones located in the proximal one-third of the gastrocnemius muscle belly and the mid-belly region of the soleus muscle. Sham rESWT is performed using the same device and positioning as real treatment. The applicator contacts the skin and provides identical auditory and vibratory feedback; however, no therapeutic energy is delivered. All individuals except the operator (participants and evaluators) remain blinded to whether a session is real or sham.

Participants are assigned to one of three parallel groups. Group 1 (Control) receives conventional physical therapy three times per week for 12 weeks (60 minutes per session) and, during the first three weeks, attends the research center twice weekly to receive sham rESWT followed by 20 minutes of stretching on both days, for a total of six sham sessions. Group 2 receives the same conventional physical therapy and, during the first three weeks, attends the research center twice weekly, receiving one session of real rESWT combined with 20 minutes of stretching and one session of sham rESWT combined with 20 minutes of stretching each week (total of three real and three sham sessions). Group 3 receives the same conventional physical therapy and, during the first three weeks, attends the research center twice weekly to receive real rESWT followed by 20 minutes of stretching on both days (total of six real sessions). Real rESWT is delivered using standardized parameters of 5 Hz frequency, 1.5 bar pressure, and 2000 shocks per session.

All clinical and ultrasonographic assessments are performed before exercise and rESWT sessions to avoid acute treatment effects and ensure standardization. Baseline demographic and clinical characteristics are recorded prior to treatment.

Evaluations will be performed at four separate time points: pre-treatment (baseline), at the end of treatment, and at 4 weeks and 12 weeks post-treatment.

• Spasticity levels will be assessed using the Tardieu Scale, Modified Ashworth Scale (MAS), and passive Range of Motion (PROM) measurements.
• The Pediatric Berg Balance Scale (PBS) will be used for balance assessment, the Modified Timed Up and Go Test (MTUG) for functional mobility, and the 10-Meter Walk Test (10MWT) for walking speed.
• For the assessment of spasticity-related pain levels, the Revised Faces Pain Scale (FPS-R), which is appropriate and validated for children, will be used.
• The mechanical properties of the muscle will be quantitatively evaluated using the Shear Wave Elastography (SWE) method; for the evaluation of muscle morphology, muscle thickness will be measured via ultrasonography, and the Modified Heckmatt Scale (MHS) will be applied to classify muscle structural properties

Enrollment: 45 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 6-14 years diagnosed with cerebral palsy according to the Rosenbaum diagnostic criteria.
• Gross Motor Function Classification System (GMFCS) level I, II, or III.
• Modified Ashworth Scale (MAS) score >1 and ≤3 in unilateral or bilateral ankle plantar flexor muscle groups.
• Presence of a spastic gait pattern characterized by a dynamic component of ankle equinus.

Exclusion criteria

• Age younger than 6 years or older than 14 years.
• Botulinum toxin type A injection or extracorporeal shock wave therapy (ESWT) within 6 months prior to enrollment.
• Fixed contracture with passive joint range of motion (ROM) <5° in the affected extremity, or significant bone or joint deformity.
• History of orthopedic surgery (tendon release or transfer, tenotomy, muscle release surgery, arthrodesis) involving the affected extremity.
• Cognitive or behavioral disorders that would prevent participation in the intervention or assessments.
• Uncontrolled systemic disease or significant comorbid conditions.
• History of neurosurgical intervention (e.g., selective dorsal rhizotomy, neurectomy).
• Presence of significant dystonia or severe movement disorder in the extremity to be evaluated.
• Presence of contraindications for ESWT application in the treatment area, including open skin lesions, skin infection, signs of active inflammation, or history of malignancy; bleeding diathesis, use of anticoagulant therapy, or circulatory problems due to vascular pathology.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Control (Conventional Physical Therapy + Sham rESWT)

Sham Comparator group

Description:

All participants continue routine neurological rehabilitation consisting of conventional physical therapy (60 minutes per session, 3 sessions per week for 12 weeks) tailored to individual goals. In this control arm, during the first 3 weeks, sham radial extracorporeal shock wave therapy (rESWT) is administered 2 days per week (total 6 sham sessions). Each session is followed by 20 minutes of stretching.

Treatment:

Device: Sham radial extracorporeal shock wave therapy (rESWT)

Other: Conventional physical therapy

1 Real rESWT Session per Week (Real + Sham)

Experimental group

Description:

All participants continue routine neurological rehabilitation consisting of conventional physical therapy (60 minutes per session, 3 sessions per week for 12 weeks) tailored to individual goals. During the first 3 weeks, rESWT is delivered 2 days per week using a hybrid schedule: one session per week of real rESWT and one session per week of sham rESWT (total 3 real and 3 sham sessions). Each session is followed by 20 minutes of stretching.

Treatment:

Device: Sham radial extracorporeal shock wave therapy (rESWT)

Device: Real radial extracorporeal shock wave therapy (rESWT)

Other: Conventional physical therapy

2 Real rESWT Sessions per Week (Real)

Experimental group

Description:

All participants continue routine neurological rehabilitation consisting of conventional physical therapy (60 minutes per session, 3 sessions per week for 12 weeks) tailored to individual goals. During the first 3 weeks, real rESWT is administered 2 days per week (total 6 real sessions). Each session is followed by 20 minutes of stretching.

Treatment:

Device: Real radial extracorporeal shock wave therapy (rESWT)

Other: Conventional physical therapy