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| Name | Class |
|---|---|
| International Clinic of Rehabilitation, Ukraine | OTHER |
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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.
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INRS with BCSK | Experimental | "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. |
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| INRS with traditional spinal manipulation | Sham Comparator | "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. |
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| Total population | Experimental | All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCSK | Procedure | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Box and Blocks test is used to measure change over time | Evaluation of fine motor skills using Box and Blocks test. The score is the number of blocks carried from one compartment to the other in one minute. Each hand is scored separately. | Baseline, 2 weeks, 6 months |
| Range of motion is used to measure change over time |
Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Forssberg, Professor | Department of Women´s and Children´s Health, Karolinska University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Clinic of Rehabilitation | Truskavets | Lviv Oblast | Ukraine |
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| ID | Term |
|---|---|
| C537945 | Cerebral palsy, spastic, diplegic |
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| Traditional spinal manipulation | Procedure | Spinal manipulation by traditional technique is a mild mobilization without impulse, based on applying gentle repetitive force without crossing restrictive barrier. |
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| INRS | Procedure | 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". |
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Range of motion measurement with goniometer in wrist, elbow, hip, knee and ankle joints. |
| Baseline, 2 weeks, 6 months |
| Boyd and Graham´s Selective Motor Control Scale is used to measure change over time | Performance of voluntary active ankle dorsiflexion according the ordinal scale, Boyd and Graham´s Selective Motor Control Scale. | Baseline, 2 weeks, 6 months |
| NeuroFlexor is used to measure change over time | Testing of muscle tone using the NeuroFlexor when applicable. The NeuroFlexor (Aggero MedTech AB, Solna, Sweden) is an instrument for objectively quantifying passive movement in wrist and finger flexor muscles. | Baseline, 2 weeks, 6 months |
| Questionnaire is used to measure change over time | Questionnaire of treatment efficiency, filled in by parents. | 2 weeks, 6 months |