Clinical trial NCT02166541: Evaluation of INRS With BCSK in Children With Spastic Bilateral Cerebral Palsy: a Randomized Controlled Trial.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Diplegia Cerebral Palsy
Keywords: cerebral palsy, spastic, diplegic,
children,
intervention study,
manipulation, spinal
randomized controlled trial
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: International Clinic of Rehabilitation, Ukraine
First posted: 2014-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gross Motor Function Measure 66 (GMFM 66) is used to measure change over time
timeFrame: Baseline, 2 weeks, 6 months
Secondary outcomes:
measure: Muscle tone testing using Modified Ashworth Scale is used to measure change over time
timeFrame: Baseline, 2 weeks, 6 months
Other outcomes:
measure: Box and Blocks test is used to measure change over time
timeFrame: Baseline, 2 weeks, 6 months
measure: Range of motion is used to measure change over time
timeFrame: Baseline, 2 weeks, 6 months
measure: Boyd and Graham´s Selective Motor Control Scale is used to measure change over time
timeFrame: Baseline, 2 weeks, 6 months
measure: NeuroFlexor is used to measure change over time
timeFrame: Baseline, 2 weeks, 6 months
measure: Questionnaire is used to measure change over time
timeFrame: 2 weeks, 6 months
Locations:
city: Truskavets
country: Ukraine
facility: International Clinic of Rehabilitation
state: Lviv
Study officials:
affiliation: Department of Women´s and Children´s Health, Karolinska University
name: Hans Forssberg, Professor
role: PRINCIPAL_INVESTIGATOR
References: