Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02719483
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
The First Hospital of Jilin University

Brief 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.

Condition or disease Intervention/treatment Phase
Muscle Spasticity Cerebral Palsy Device: Swiss DolorClast Procedure: Traditional conservative therapy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Applied Research in Children With Spastic Cerebral Palsy in the Extracorporeal Shock Wave Therapy
Study Start Date : April 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: rESWT + traditional conservative therapy
Radial extracorporeal shock wave therapy (rESWT) performed with the Swiss DolorClast device (EMS Electro Medical Systems, Nyon, Switzerland) plus traditional conservative therapy.
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).

Traditional conservative therapy
Traditional conservative therapy alone.
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).




Primary Outcome Measures :
  1. Modified Ashworth Scale (MAS) grade of the plantar flexor muscles [ Time Frame: Three months after baseline ]
    MAS grade collected on each side at baseline (BL), one month (M1) and three months (M3) after BL. For the patients in the rESWT group, the MAS grade collected before rESWT at BL and after rESWT at M1 and M3. MAS grades are respectively 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) moved in flexion or extension), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved), 3 (considerable increase in muscle tone, passive movement difficult) or 4 (affected part(s) rigid in flexion or extension).


Secondary Outcome Measures :
  1. Passive range of motion of the foot (pROM) [ Time Frame: Three months after baseline ]
    pROM measured at BL, M1 and M3 as the dorsiflexion of the ankle joint. Measurements performed using a goniometer in supine position with the knee extended. For the patients in the rESWT group, pROM measurements performed before rESWT at BL and after rESWT at M1 and M3. Besides this, on the left side, pROM measurements also performed after rESWT at BL and before rESWT at M1 and M3.

  2. Gross Motor Function Measure (GMFM)-88 [ Time Frame: Three months after baseline ]
    GMFM-88 collected at BL and M3. For the patients in the rESWT group, GMFM-88 collected before rESWT at BL and after rESWT at M3. The GMFM-88 is a standardized criterion referenced measurement tool designed to measure gross motor function over time for children with disabilities between five months and six years of age. It considers five dimensions of gross motor function: lying and rolling (17 items), sitting (20 items), crawling and kneeing (14 items), standing (13 items), and walking, running and jumping (24 items). A recent literature review considered the GMFM-88 useful as an outcome measure to detect changes in gross motor function in children with CP undergoing interventions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of cerebral palsy
  • spasticity of plantar flexor muscles greater than Grade 1 and up to Grade 4 according to the modified Ashworth scale
  • availability to attend the hospital during the treatment and follow-up assessments

Exclusion Criteria:

  • fixed contractures or deformities at the left ankle
  • myopathies
  • clinical signs of myopathy and neuropathy
  • treatment with shock waves in the past
  • treatment with Botulinum neurotoxin A and/or focal intramuscular treatment with phenol and alcohol in the past
  • previous surgery of the left foot, ankle and leg
  • treatment with drugs for spasticity control
  • infection or tumor at the site of therapy application*
  • serious blood dyscrasia*
  • blood-clotting disorders*
  • treatment with oral anticoagulants*

(*, contraindications of radial extracorporeal shock wave therapy)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719483


Sponsors and Collaborators
The First Hospital of Jilin University
Investigators
Layout table for investigator information
Principal Investigator: Feiyong Jia, MD Department of Pediatric Neurology and Neurorehabilitation, First Hospital of Jilin University, Changchun, China
Layout table for additonal information
Responsible Party: The First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT02719483    
Other Study ID Numbers: 20141030
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The First Hospital of Jilin University:
Children
Spasticity
Extracorporeal shock wave therapy
Cerebral palsy
Gross motor function
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations