Spastic Diplegia Cerebral Palsy
Conditions
Keywords
cerebral palsy, spastic, diplegic,, children,, intervention study,, manipulation, spinal, randomized controlled trial
Brief summary
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
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; 1. To evaluate the effect of Biomechanical Correction of the Spine (BCSK) in children with Spastic Bilateral Cerebral Palsy. 2. To evaluate the effect of Intensive Neurophysiological Rehabilitation System (INRS) in children with Spastic Bilateral Cerebral Palsy.
Interventions
PROCEDUREBCSK
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.
PROCEDURETraditional spinal manipulation
Spinal manipulation by traditional technique is a mild mobilization without impulse, based on applying gentle repetitive force without crossing restrictive barrier.
PROCEDUREINRS
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.
Sponsors
International Clinic of Rehabilitation, Ukraine
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measure 66 (GMFM 66) is used to measure change over time | Baseline, 2 weeks, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle tone testing using Modified Ashworth Scale is used to measure change over time | Baseline, 2 weeks, 6 months | Estimation of muscle tone during rapid passive extension of the tested muscle-groups according to an ordinal scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Range of motion is used to measure change over time | Baseline, 2 weeks, 6 months | Range of motion measurement with goniometer in wrist, elbow, hip, knee and ankle joints. |
| Questionnaire is used to measure change over time | 2 weeks, 6 months | Questionnaire of treatment efficiency, filled in by parents. |
| NeuroFlexor is used to measure change over time | Baseline, 2 weeks, 6 months | 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. |
| Boyd and Graham´s Selective Motor Control Scale is used to measure change over time | Baseline, 2 weeks, 6 months | Performance of voluntary active ankle dorsiflexion according the ordinal scale, Boyd and Graham´s Selective Motor Control Scale. |
| Box and Blocks test is used to measure change over time | Baseline, 2 weeks, 6 months | 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. |
Countries
Ukraine
Outcome results
None listed