An interventional study of BCSK and Traditional spinal manipulation in Spastic Diplegia Cerebral Palsy, sponsored by Karolinska Institutet. Completed at 1 site in Ukraine. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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;
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 60 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
"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 · Procedure: INRS
"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 · Procedure: INRS
All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)
Procedure: BCSK · Procedure: Traditional spinal manipulation · Procedure: INRS
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.
Spinal manipulation by traditional technique is a mild mobilization without impulse, based on applying gentle repetitive force without crossing restrictive barrier.
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".
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.
Time frame: Baseline, 2 weeks, 6 months
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.
Time frame: Baseline, 2 weeks, 6 months
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.
Time frame: Baseline, 2 weeks, 6 months
Range of motion is used to measure change over time
Range of motion measurement with goniometer in wrist, elbow, hip, knee and ankle joints.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2 weeks, 6 months
Questionnaire is used to measure change over time
Questionnaire of treatment efficiency, filled in by parents.
Time frame: 2 weeks, 6 months
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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