Physiotherapy After Botulinum Toxin Injection and Serial Casting

Study Overview
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Brief Summary
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The effects of different physiotherapy programs on children with cerebral palsy who have been received botulinum toxin injection and serial casting application will be determined.

Detailed Description
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CP children who underwent botulinum toxin injection to medial gastrocnemius muscle and serial casting application in last two months will be included in the study. The effects of traditional physiotherapy and downhill backward treadmill training plus to traditional physiotherapy on muscle morphology, activity, walking, quality of life and selectivity will be determined.

Official Title
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Comparison of the Effectiveness of Different Physiotherapy and Rehabilitation Programs After Onabotulinum Toxin-A Injection and Serial Casting in Children With Cerebral Palsy

Conditions
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Cerebral Palsy, Cerebral Palsy, Spastic

Intervention / Treatment
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* Procedure: backward downhill walking
* Procedure: routine physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being diagnosed with cerebral palsy (CP) (hemiplegic-diplegic) To have undergone botulinum toxin and serial casting interventions in the last 2 months to be between 5-10 years old Being at the level of I-II-III (ambulatory or assisted ambulatory) according to Gross Motor Function Classification System To have the mental competence to understand and apply assessments and exercises Exclusion Criteria: Having undergone surgery involving the lower extremity in the last 6 months Refusing to participate in the study Having other accompanying neurometabolic or orthopedic disorders

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 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
Interventional Model Description: 2 groups of children with Cerebral palsy are going to be involved at the same time. One of the groups will be enrolled in the routine physiotherapy intervention. The other group will be enrolled to the routine physiotherapy intervention + backward downhill walking.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>Children in this group will take routine physiotherapy (stretching, strengthening) program during 6 weeks. 3 days/week. | Procedure: routine physiotherapy<br>* Children in one of the groups will take routine physiotherapy programme<br>|
| Active Comparator: intervention group<br>Children in this group will take routine physiotherapy (stretching, strengthening) program + backward downhill walking (10 minutes in a day) during 6 weeks. 3 days/week. | Procedure: backward downhill walking<br>* Children in the intervention group will take backward downhill walking program plus to routine physiotherapy.<br>Procedure: routine physiotherapy<br>* Children in one of the groups will take routine physiotherapy programme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle morphology | Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements | Before the intervention | 
| Muscle morphology | Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements | After six weeks intervention | 
| Vascularization | Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements | Before the the intervention | 
| Vascularization | Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements | After six weeks intervention | 
| Muscle strenght | Will be measured by manual muscle tester | Before the intervention | 
| Muscle strenght | Will be measured by manual muscle tester | After six weeks intervention | 
| Range of motion | Will be measured with goniometer | Before the intervention. | 
| Range of motion | Will be measured with goniometer | After six weeks intervention | 
| Edinburgh visual gait analysis | Gait will be recorded as video and this video will be scored | Before the intervention | 
| Edinburgh visual gait analysis | Gait will be recorded as video and this video will be scored | After six weeks intervention | 
| Modified Tardieu Scale | Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity | Before the intervention | 
| Modified Tardieu Scale | Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity | After six weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data | Face-to-face interview with family. Will be recorded in data registration form | Before the intervention | 
| Demographic data | Face-to-face interview with family. Will be recorded in data registration form | After six weeks intervention | 
| Child Health Questionnare (Parent form) | Quality of life will be measured by this questionnare | Before the intervention | 
| Child Health Questionnare (Parent form) | Quality of life will be measured by this questionnare | After six weeks intervention | 
| Children Functional Independence Measurement Scale | Functional Independency will be measured by this scale. Higher scores mean better independence. | Before the intervention | 
| Children Functional Independence Measurement Scale | Functional Independency will be measured by this scale. Higher scores mean better independence. | After six weeks intervention | 
| Lower extremity selective control measurement | Selective movement will be measured with this scale. Higher scores mean better selective control. | Before the intervention | 
| Lower extremity selective control measurement | Selective movement will be measured with this scale. Higher scores mean better selective control. | After six weeks intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, botulinum toxin, serial casting, physiotherapy, muscle morphology