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Effect of Session Frequency of rESWT on Gastrocnemius Muscle Spasticity in Children With Spastic Type Cerebral Palsy

NCT04574622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-10-05

No results posted yet for this study

Summary

Spasticity, defined as a velocity dependent increase in tonic stretch reflexes, is one of the most prominent motor problems that occur in patients with cerebral palsy (CP). This causes difficulty in achieving balance, mobility, and an upright stance. CP is a group of permanent disorders that affect the development of movement and posture caused by a non-progressive damage to the brain. Because CP occurs in 2-3 of 1000 individuals, it is one of the most common causes of severe physical disability in children.

Mismanagement of spasticity can lead to contracture which is extremely difficult to treat and may result in severe functional disabilities. The current management of spasticity in CP includes physical therapy (i.e. passive stretching), oral medication, botulinum toxin injection, and surgery. Botulinum toxin injection has been proven to effectively reduce spasticity yet many patients are unable to get access to this treatment due to its high cost. Moreover, Botulinum toxin injection is currently not covered by the public health insurance of Indonesia. Therefore, other modalities which are more affordable and are non-invasive therapies should be considered as a treatment option for spasticity.

Radial Extracorporeal Shockwave Therapy (rESWT) has been utilized in the medical practice for the treatment of several musculoskeletal disorders such as chronic tendinopathies and spasticity. It is hypothesized that ESWT has two main effects which include a direct effect from mechanical forces at the treatment point and an indirect effect from cavitation. Even though rESWT has less penetration capacity over the focused Extracorporeal Shockwave Therapy (fESWT), rESWT is still believed to be more superior to fESWT because it requires less precise focusing, is less painful, and costs less. These also make rESWT the more appropriate choice for children with CP.

Many studies have proven the efficacy of ESWT in reducing spasticity in spastic CP patients with significantly long lasting effects. Despite promising results, there still has yet to be a recommended guideline for the treatment of spasticity in children using rESWT. One of the critical parameters needed to be determined is the frequency of treatment. Therefore, the objective of this study is to understand whether the reduction in gastrocnemius stiffness in children with spastic CP is influenced by the frequency of ESWT sessions.

Conditions

  • Spasticity, Muscle
  • Cerebral Palsy
  • Child; Spastic

Interventions

DEVICE

radial Extracorporeal Shockwave Therapy

rESWT was given on gastrocnemius muscles with the subject lying on prone position. No anesthesia was required.

Sponsors & Collaborators

  • Rizky Kusuma Wardhani

    lead OTHER

Principal Investigators

  • Rizky K Wardhani, M.D., Physiatrist · Universitas Indonesia Fakultas Kedokteran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2020-06-17
Completion
2020-06-17

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04574622 on ClinicalTrials.gov