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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Gross Motor Function Measure 66 (GMFM 66) is used to measure change over time
Study Overview
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;
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
INRS with BCSK
"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.
Intervention: BCSK (Procedure)
Total population
All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)
Intervention: BCSK (Procedure)
Total population
All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)
Intervention: Traditional spinal manipulation (Procedure)
Total population
All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)
Intervention: INRS (Procedure)
INRS with BCSK
"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.
Intervention: INRS (Procedure)
INRS with traditional spinal manipulation
"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.
Intervention: Traditional spinal manipulation (Procedure)
INRS with traditional spinal manipulation
"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.
Intervention: INRS (Procedure)
Outcomes
Primary Outcomes
Gross Motor Function Measure 66 (GMFM 66) is used to measure change over time
Time Frame: 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 Outcomes
- Muscle tone testing using Modified Ashworth Scale is used to measure change over time(Baseline, 2 weeks, 6 months)
Investigators
Hans Forssberg
Professor
Karolinska Institutet