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Effect of Number of Pulses of Radial Extracorporeal Shock Wave Therapy on Hamstring Spasticity in Children With Cerebral Palsy

NCT04546035 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-09-11

No results posted yet for this study

Summary

Cerebral palsy (CP) is a group of permanent disorders affecting movement and postural development that are caused by non-progressive disruptions of the brain, usually occurring during fetal period or infancy. It is commonly accompanied with sensory disorders and learning disability. In 2016, more than 17 million people are affected by CP with a prevalence of 1.5 to 2.5 per 1,000 live births. CP remains to be the most common cause of severe physical disability in children. The Centres for Disease Control and Prevention (CDC) estimated an economic cost of US$4.1 million per CP patient that comprises of medical services, special education and productivity loss.

Current management of spasticity involves physical manipulation such as passive stretching and splinting, sometimes combined with oral pharmacologic treatment, intrathecal baclofen therapy and botulinum toxin injection. At times, surgical procedures such as Surgical Dorsal Rhizotomy (SDR) can also be considered. Botulinum toxin injection has been shown to reduce spasticity for up to 6 months, however, the cost of the procedure remains to be an issue in developing countries like Indonesia. Therefore, other modality such as a non-invasive therapy should be considered as an alternative treatment for spasticity.

Radial Extracorporeal Shockwave Therapy (rESWT) is a non-invasive treatment that has been shown to effectively improve spasticity in patients with spastic motor type CP, despite unclear underlying mechanism. According to International Society for Medical Shockwave Treatment (ISMST), there has yet to be a recommended guideline for the treatment of spasticity in children using rESWT. One crucial physical parameter needed to be determined is the number of pulse required to efficiently reduce spasticity. The number of pulse directly affects the duration of ESWT per session (the higher the number of pulse given, the longer the therapy session). This may be a concern for spastic motor type CP due to accompanying sensory and learning disability. Therefore, the objective of this study was to understand whether the reduction in hamstring stiffness in children with spastic CP could be influenced by the number of pulse in a single ESWT session.

Conditions

  • Spasticity, Muscle
  • Cerebral Palsy
  • Child; Spastic

Interventions

DEVICE

radial Extracorporeal Shockwave Therapy

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

Sponsors & Collaborators

  • Rizky Kusuma Wardhani

    lead OTHER

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
2020-03-26
Completion
2020-03-26

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 NCT04546035 on ClinicalTrials.gov