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Radial Extracorporeal Shock Wave Therapy for Spastic Plantar Flexor Muscles in Young Children With Cerebral Palsy

NCT02719483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2016-03-25

No results posted yet for this study

Summary

The purpose of this study is to determine whether radial extracorporeal shock wave therapy in combination with traditional physical therapy is safe and effective for the management of spastic plantar flexor muscles in patients with cerebral palsy younger than averaged three years of age.

Conditions

  • Muscle Spasticity
  • Cerebral Palsy

Interventions

DEVICE

Swiss DolorClast

"Radial" (blue) handpiece; one rESWT session per week for three months, with 1500 radial shock waves per session and leg, i.e., a total of 3000 radial shock waves per session or a total of 36.000 radial shock waves within twelve weeks; radial shock waves evenly distributed over the gastrocnemius and soleus muscles; air pressure of the device set at 0.6 bar, resulting in a positive energy flux density (EFD+) of 0.03 mJ/mm2; radial shock waves applied at a frequency of 8 Hz; local or general anesthesia not applied.

PROCEDURE

Traditional conservative therapy

Physical therapy, Chinese massage, meridian mediation and muscle stimulation for three months (six days per week, 30 min per type of therapy).

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Principal Investigators

  • Feiyong Jia, MD · Department of Pediatric Neurology and Neurorehabilitation, First Hospital of Jilin University, Changchun, China

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-07-31
Completion
2016-03-31

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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 NCT02719483 on ClinicalTrials.gov