Shock Wave and Spastic Cerebral Palsy Equines Foot

Study Overview
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Brief Summary
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A double-blind randomized controlled study was carried out on 34 children (19 boys and 15 girls) in the age ranged from 7 to 9 years old with spastic hemiplegia were randomly allocated to one of two groups: control or study group. The two groups received traditional therapeutic exercises for 12 weeks. Additionally, study group received rESW (one session/week) on gastrocnemius and soleus muscles (1500 shots/muscle, frequency of 4Hz, energy of 0.030 mJ/mm2). All children were evaluated at baseline, and after 12 weeks by Modified Ashworth Scale, Biodex system 4 isokinetic dynamometer, Gross Motor Function Measure (GMFM-88), dimensions D standing and E walking, Trost Selective Motor Control Test, and Single Leg Standing Test.

Detailed Description
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Both groups underwent conventional physical therapy program which included muscle stretching, strengthening exercises, neurodevelopmental techniques, proprioceptive training, and balance and gait training for three months (3 days/week ,1 hour/day). Study group Subjects in this group received the traditional physical therapy treatment plus true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week) of shock wave intervention. The pressure pulses were focused on the muscle belly of the planter flexor hypertonic muscles. Standard ultrasonic gel was used as a contact medium. A total of 1500 shots with a pressure of 1.5 bar and an energy flux density (EFD) of 0.030 mJ/mm2 were applied with the repetition frequency of shock wave irradiation of 4 pulses per second (Hz). The rESW session lasted about 6 minutes and was painless; thus, local anesthesia was not required.

Official Title
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Effects Of Extracorporeal Shock Wave On Spastic Equines Foot In Children With Hemiplegic Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: shock wave
* Other: traditional physical therapy program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) children who could walk independently or with assistive devices ,2) children with motor dysfunction graded as a 1 or 2 on the Gross Motor Function Classification System (GMFCS), 3) children scoring 1or1+ on the Modified Ashworth Scale (MAS), 4) Dynamic ankle contracture which was confirmed if ankle equinus was observed during ambulation and passive dorsiflexion of the ankle could be accomplished beyond the neutral position with knee extended Exclusion Criteria: 1) children older than 9 years or younger than 7 years, 2) previous botulinum toxin type A injection in the gastrocnemius muscle or serial casting of the ankle within 6 months prior to enrollment, 3) fixed ankle contracture, and 4) surgery of the lower limbs in the past 12 months.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>received the traditional physical therapy program as muscle stretching and strengthening and neurodevelopmental techniques, proprioceptive training, and balance and gait training plus shock wave on the muscle belly of the planter flexor hypertonic muscles. | Device: shock wave<br>* true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week)<br>Other: traditional physical therapy program<br>* lower limbs muscles stretch and strength in addition to balance and gait training<br>|
| Other: control group<br>received the traditional physical therapy program as muscle stretching and strengthening and neurodevelopmental techniques, proprioceptive training, and balance and gait training .these traditional therapy had been approved by previous studies its effectiveness in management cerebral palsy child | Other: traditional physical therapy program<br>* lower limbs muscles stretch and strength in addition to balance and gait training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodex system | The Biodex system 4 (Biodex Medical, Shirley, NY, USA) was used for the quantitative biomechanical assessment of the spasticity of the affected side ankle plantar flexor muscle | 12 weeks | 
| The modified Ashworth scale | The modified Ashworth scale, which is a six-point ordinal scale for grading (0, 1, 1+, 2, 3, and 4) was applied for clinical assessment of spasticity of ankle plantar flexors. | 12 weeks | 
| Single Leg Standing Test (SLS) | The SLS is a simple and effective test to assess static balance. It is conducted by measuring the time that a child can maintain balance by lifting the foot according to the signal Start. The average of three measures was used. | 12 weeks | 
| The Trost Selective Motor Control test (TSMC) | The TSMC test was used to assess ability of the child to perform isolated movement of the ankle. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Extracorporeal Shock Wave Therapy, Hemiplegia, selective motor control