Evaluation of INRS With BCSK in Children With Spastic Bilateral Cerebral Palsy: a Randomized Controlled Trial.

Not Applicable

Completed

• Conditions: Spastic Diplegia Cerebral Palsy
• Interventions: Procedure: BCSK; Procedure: Traditional spinal manipulation; Procedure: INRS

• Registration Number: NCT02166541
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-18
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

• Other forms of Cerebral Palsy
• Severe epileptic syndrome
• Severe mental retardation
• Orthopedic surgery within the last year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total population	BCSK	All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)
INRS with BCSK	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.
INRS with traditional spinal manipulation	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.
INRS with traditional spinal manipulation	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.
Total population	INRS	All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)
INRS with BCSK	INRS	"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.
Total population	Traditional spinal manipulation	All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

International Clinic of Rehabilitation; 🇺🇦 Truskavets, Lviv, Ukraine