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

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.

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.

Study Overview

• Status: Completed
• Conditions: Spastic Diplegia Cerebral Palsy
• Intervention / Treatment: Procedure: BCSK; Procedure: INRS; Procedure: Traditional spinal manipulation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Lviv
    • Truskavets, Lviv, Ukraine
      • International Clinic of Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: BCSK; 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.; Procedure: INRS; 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".
Sham Comparator: 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.	Procedure: INRS; 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".; Procedure: Traditional spinal manipulation; Spinal manipulation by traditional technique is a mild mobilization without impulse, based on applying gentle repetitive force without crossing restrictive barrier.
Experimental: Total population; All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)	Procedure: BCSK; 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.; Procedure: INRS; 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".; Procedure: Traditional spinal manipulation; Spinal manipulation by traditional technique is a mild mobilization without impulse, based on applying gentle repetitive force without crossing restrictive barrier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2 weeks, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2 weeks, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, 2 weeks, 6 months
Questionnaire is used to measure change over time	Questionnaire of treatment efficiency, filled in by parents.	2 weeks, 6 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: International Clinic of Rehabilitation, Ukraine
• Investigators: Principal Investigator: Hans Forssberg, Professor, Department of Women´s and Children´s Health, Karolinska University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimated): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; children,; cerebral palsy, spastic, diplegic,; intervention study,; manipulation, spinal
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Paralysis; Muscle Spasticity
• Other Study ID Numbers: Forssberg_KI_1