Efficacy of Extracorporeal Shock Wave Therapy in Children With Cerebral Palsy

Study Overview
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Brief Summary
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Spastic plantar and palmar flexion deformities are very common in children with cerebral palsy (CP). These deformities usually involve spasticity of the plantar or palmar muscle complexes, weakness of the antagonist dorsiflexor muscles of the ankle or wrist, and also involve soft tissue/muscle contractures and require a multimodal treatment approach. Physical therapy (PT), occupational therapy (OT), serial casting (SC), and botulinum toxin A (BoNT-A) injections had shown positive results in both of these deformities. Recent systematic reviews and meta-analyses showed that extracorporeal shock wave therapy (ESWT) is effective in reducing spasticity, pain intensity, and increasing range of motion and motor function when combined with PT or BoNT-A injections in neurological conditions like stroke, CP, multiple sclerosis. ESWT can be a complimentary therapy to obtain an earlier efficacy, better efficacy, a sustained effect for a longer period, and less adverse events. The objective of this study was to show the effects of ESWT when combined with intermittent SC, BoNT-A injections and PT or OT on spasticity, passive range of motion (pROM) of children with CP having spastic equinus foot deformity or wrist palmar flexion deformity.

Detailed Description
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Spasticity is one of the most common motor disorder which may slowly cause soft tissue contractures in children with CP. Spastic plantar and palmar flexion deformities are very common in children with CP. These deformities usually involve spasticity of the plantar or palmar muscle complexes, weakness of the antagonist dorsiflexor muscles of the ankle or wrist, and also involve soft tissue/muscle contractures. PT, OT, SC, and BoNT-A injections had shown positive results in both of these deformities. Skin irritation or breakdown, painful episodes, oedema, tendonitis, weakness, stiffness are some of the side effects reported after SC. Moreover casting especially when prolonged might complicate activities of daily living for instance by increasing the risk of falls or causing problems in bathing. Recent evidence from literature favors early, goal oriented, activity based, intensive, repetitive motor trainings in enriched environments to optimize neuroplasticity in children with CP. Prolonged SC might also interfere with these activity based, intensive rehabilitation options for upper extremity. In order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed and used both for children with CP presenting equines foot deformity or palmar flexion deformity. Combined management of intermittent SC, and BoNT-A injections had shown better results compared to either treatment alone in both of these deformities. Recent systematic reviews and meta-analyses showed that ESWT is effective in reducing spasticity, pain intensity, and increasing range of motion and motor function when combined with PT or BoNT-A injections in neurological conditions like stroke, CP, multiple sclerosis. ESWT can be a complementary therapy to obtain an earlier efficacy, better efficacy, a sustained effect for a longer period, and less adverse events. The objective of this study was to show the effects of ESWT when combined with intermittent SC, BoNT-A injections and PT or OT on spasticity, passive range of motion (pROM) of children with CP having spastic equinus foot deformity or wrist palmar flexion deformity.

Official Title
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Efficacy of Extracorporeal Shock Wave Therapy Integrated to Combined Treatment of Botulinum Toxin A and Serial Casting in Children With Cerebral Palsy

Conditions
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Spasticity/Paresis, Cerebral Palsy

Intervention / Treatment
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* Device: ESWT
* Drug: Botulinum Toxin Type A
* Other: Serial Casting
* Behavioral: Physical Therapy
* Behavioral: Occupational Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a diagnosis of CP according to Rosenbaum criteria, presenting plantar or palmar flexion deformity, having a Modified Ashworth Scale score of 3 in plantar or palmar flexor muscle groups, being scheduled for BoNT-A treatment, intermittent serial casting and physical or occupational therapy Exclusion Criteria: Having cognitive dysfunction, having a history of orthopedic surgery, presenting significant dystonia, having vascular disease, fracture, or dislocation

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 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: ESWT Group<br>Patients treated by BoNT-A, intermittent SC and ESWT, whom received either PT or OT | Device: ESWT<br>* Extracorporeal Shock Wave Therapy<br>Drug: Botulinum Toxin Type A<br>* Botulinum Toxin Type A<br>* Other names: Botox;Other: Serial Casting<br>* Serial Casting<br>Behavioral: Physical Therapy<br>* Physical Therapy<br>Behavioral: Occupational Therapy<br>* Occupational Therapy<br>|
| Active Comparator: Control Group<br>Patients treated by BoNT-A, and intermittent SC, whom received either PT or OT | Drug: Botulinum Toxin Type A<br>* Botulinum Toxin Type A<br>* Other names: Botox;Other: Serial Casting<br>* Serial Casting<br>Behavioral: Physical Therapy<br>* Physical Therapy<br>Behavioral: Occupational Therapy<br>* Occupational Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline Tardieu XV3 angle | Spasticity measurement | Post-treatment weeks 4-6 | 
| Mean change from baseline passive range of movement | Soft tissue contracture measurement | Post-treatment weeks 12-20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goal Attainment Scale-Light | Attainment of treatment goals 5 point scale ranging from -2 to 2, higher score representing better outcome | Post-treatment weeks 4-12-20 | 
| Faces Pain Scale | Assessment of pain by a visual 6 point scale ranging from 0 to 10, 0 representing no pain, 10 representing most excruciating pain | Post-treatment weeks 4-12-20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spasticity, Cerebral Palsy, Botulinum toxin A, Extracorporeal Shock Wave Therapy, Casting