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

NCT02719483 | Completed

• 1 other identifier: 20141030
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Muscle Spasticity; Cerebral Palsy

Keywords

Children; Spasticity; Extracorporeal shock wave therapy; Cerebral palsy; Gross motor function

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale (MAS) grade of the plantar flexor muscles

  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).

  Three months after baseline

Secondary Outcomes (2)

• Passive range of motion of the foot (pROM)

  Three months after baseline

• Gross Motor Function Measure (GMFM)-88

  Three months after baseline

Study Arms (2)

rESWT + traditional conservative therapy

ACTIVE COMPARATOR

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; Procedure: Traditional conservative therapy

Traditional conservative therapy

OTHER

Traditional conservative therapy alone.

Procedure: Traditional conservative therapy

Interventions

Swiss DolorClast DEVICE

"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.

rESWT + traditional conservative therapy

Traditional conservative therapy PROCEDURE

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; rESWT + traditional conservative therapy

Eligibility Criteria

• Age: 12 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Muscle Spasticity; Cerebral Palsy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Feiyong Jia, MD

  Department of Pediatric Neurology and Neurorehabilitation, First Hospital of Jilin University, Changchun, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 25, 2016
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 25, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share