Evaluation of INRS With BCSK in Children With Spastic Bilateral Cerebral Palsy: a Randomized Controlled Trial.

Study Overview
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Brief Summary
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A randomized control trial investigating Biomechanical Correction of the Spine according to Kozyavkin (BCSK) which is a part of the treatment concept Intensive Neurophysiological Rehabilitation System (INRS). BCSK is used with the aims to reduce muscle tone and improve gross and fine motor function in children with Spastic Bilateral Cerebral Palsy.

Detailed Description
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The study is a collaboration between the International Clinic of Rehabilitation (ICR) in Ukraine and the Karolinska Institute (KI) in Sweden. The intervention and the assessments are performed at ICR. The primary outcome measure, evaluation of gross motor function with the test GMFM 66 is filmed and the recordings are transferred to KI together with all assessment data. KI are responsible for study research design and collects, analyzes and processes all data. It is a double blinded study. Only two persons will know to which group the subject belongs, the person performing the randomization process in Sweden and the doctor performing the spinal corrections. There are two aims of the study; To evaluate the effect of Biomechanical Correction of the Spine (BCSK) in children with Spastic Bilateral Cerebral Palsy. To evaluate the effect of Intensive Neurophysiological Rehabilitation System (INRS) in children with Spastic Bilateral Cerebral Palsy.

Official Title
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Evaluation of Intensive Neurophysiological Rehabilitation System (INRS) With Biomechanical Correction of the Spine According to Kozyavkin (BCSK) in Children With Spastic Bilateral Cerebral Palsy: a Randomized Controlled Trial.

Conditions
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Spastic Diplegia Cerebral Palsy

Intervention / Treatment
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* Procedure: BCSK
* Procedure: Traditional spinal manipulation
* Procedure: INRS


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Children with Spastic Bilateral form of Cerebral Palsy according Surveillance of Cerebral Palsy in Europe (SCPE) criteria GMFCS levels II-IV The children should not have received previous INRS treatment Exclusion Criteria: Other forms of Cerebral Palsy Severe epileptic syndrome Severe mental retardation Orthopedic surgery within the last year

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INRS with BCSK<br>Intensive Neurophysiological Rehabilitation System (INRS) including the Biomechanical correction of the spine according to Kozyavkin (BCSK). The daily treatment for about 2 hours are in general equal for all children except for the type of spinal manipulation. Duration of all treatment will be noted in a Treatment Diary. | Procedure: BCSK<br>* The BCSK is a specific technique of polysegmental spinal manipulation developed by Professor Kozyavkin based on applying quick short impulse aimed on moving intervertebral joints outside restrictive barrier.<br>Procedure: INRS<br>* The INRS is a treatment program developed at the International Clinic of Rehabilitation where the spinal manipulation is one of several components. There may be some variation in treatment depending on the clinical situation. All children receive the main treatment components which are massage, physical therapy, warm wax and paraffin applications and low electro stimulation with a special portable device as a part of treatment called Reflexotherapy.<br>|
| Sham Comparator: INRS, traditional spinal manipulation<br>Intensive Neurophysiological Rehabilitation System (INRS) including spinal manipulation by the traditional technique. The daily treatment for about 2 hours are in general equal for all children except for the type of spinal manipulation. Duration of all treatment will be noted in a Treatment Diary. | Procedure: Traditional spinal manipulation<br>* Spinal manipulation by traditional technique is a mild mobilization without impulse, based on applying gentle repetitive force without crossing restrictive barrier.<br>Procedure: INRS<br>* The INRS is a treatment program developed at the International Clinic of Rehabilitation where the spinal manipulation is one of several components. There may be some variation in treatment depending on the clinical situation. All children receive the main treatment components which are massage, physical therapy, warm wax and paraffin applications and low electro stimulation with a special portable device as a part of treatment called Reflexotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measure 66 (GMFM 66) is used to measure change over time | The Gross Motor Function Measure (GMFM) evaluates gross motor function in children with cerebral palsy. This version, GMFM 66, contains 66 items that span the spectrum from activities in lying and rolling up to walking, running and jumping skills. | Baseline, 2 weeks, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle tone testing using Modified Ashworth Scale is used to measure change over time | Estimation of muscle tone during rapid passive extension of the tested muscle-groups according to an ordinal scale. | Baseline, 2 weeks, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, spastic, diplegic,, children,, intervention study,, manipulation, spinal, randomized controlled trial